Class IIDeviceOngoing

Healthmark Industries Co., Inc.

Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT GUARD 3/16 X 1 - YELLOW, Model Number 09-1-015; 10) YELLOW VENTED INSTRUMENT GUARD 3/16 X 1, Model Number 09-1-015; 11) VENTED INSTRUMENT GUARD 13/32 X 3/4 - MAROON, Model Number 09-1-016; 12) MAROON VENTED INSTRUMENT GUARD 13/32 X 3/4, Model Number 09-1-016; 13) MAROON VENTED INSTRU GUARD 13/32 X 3/4, Model Number 09-1-016; 14) VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1 - ORANGE, Model Number 09-1-017; 15) ORANGE VENTED INSTRUMENT GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 16) OR VENTED INSTRU GUARD 1/16 X 3/8 X 1, Model Number 09-1-017; 17) VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1 - BROWN, Model Number 09-1-018; 18) BROWN VENTED INSTRUMENT GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 19) BROWN VENTED INSTRU GUARD 5/64 X 5/8 X 1, Model Number 09-1-018; 20) VENTED INSTRUMENT GUARD 1/8 X 1 X 1 - BLACK, Model Number 09-1-019; 21) BLACK VENTED INSTRUMENT GUARD 1/8 X 1 X 1, Model Number 09-1-019; 22) BLACK VENTED INSTRU GUARD 1/8 X 1 X 1, Model Number 09-1-019; 23) OPAQUE ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 24) OPAQUE COLOR - ASSORTED VENTED INSTRUMENT GUARDS, Model Number 09-1-020; 25) VENTED INSTRUMENT GUARD 1/16 X 3/4 - TRANSPARENT BLUE, Model Number 09-2-011;

Reason for recall

Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

Details

Recall number: Z-0188-2027
Event ID: 99943
Recall initiated: Sep 7, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 12,835,920 units
Distribution: Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA, CANADA, PORTUGAL, FRANCE, POLAND, PUERTO RICO, SAUDI ARABIA, HONG KONG, BAHRAIN, QATAR, OMAN, ISRAEL, MEXICO, UNITED ARAB EMIRATES, SINGAPORE, BERMUDA, SOUTH KOREA, THAILAND, and UNITED KINGDOM.
Initiated by: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Firm location: Fraser, MI, United States
Lot / code info: Model Number 09-1-011, UDI DI 00840113213610, Lot Number 46313; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 85979; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 88504; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 92954; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 95456; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 96593; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 154671; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 166797; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 168628; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 175315; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 181731; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 187198; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 188727; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 197096; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 202330; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205350; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 205390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212318; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212526; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 218245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 221829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 222154; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 223718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 229372; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 231155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 235520; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 236774; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 240155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 242716; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 246432; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 247558; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 249963; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 251383; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 255148; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 258946; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 260731; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 264390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 268142; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 283481; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 285927; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 286004; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 291423; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 294844; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 297200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 299094; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 306959; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 309214; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312858; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312892; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 319749; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 340090; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 343009; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 350257; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 351368; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 357006; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360264; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 364439; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 367841; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 368200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372770; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374801; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374847; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 385955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 388236; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 393457; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 443178; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 443178; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 493002; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 100000591; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 103829; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 107222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 112086; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 125652; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 54316; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 56859; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 77955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 93535; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 99366; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 240155; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 286004; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 291423; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 368200; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 091011; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 48704; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 68451; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 81204; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 258946; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 340090; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 350257; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 187198; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 52563; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 62805; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 66222; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 70818; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 76638; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 283481; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 351368; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 247558; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 255148; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360718; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 212526; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 312892; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 319749; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 149058; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 343009; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 218245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 388236; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 294844; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 306959; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 360264; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 188727; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 175315; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 462400; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 201659; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 264390; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 372245; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 374801; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 141843; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 130885; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 268142; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 364439; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 116183; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 385955; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 145497; Model Number 09-1-011, UDI DI 00840113213610, Lot Number 161613; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 44095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 49677; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 51509; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 54643; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 56860; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 58148; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62394; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62634; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 68585; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 70021; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 76649; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 79457; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 81514; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 86249; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 90304; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 091012; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 95567; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 101994; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 104403; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 108216; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 114714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 120256; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 124928; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 128783; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137736; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137737; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 146848; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 148709; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 151248; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 154714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 158427; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 160077; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 168636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 174867; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 185284; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 193382; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 195843; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 205443; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 213869; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 214458; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 221383; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224061; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224341; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224440; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 224461; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 229250; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 233593; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 240154; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 245111; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 247200; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 249976; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 250613; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 255573; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259566; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259702; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 267616; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 269041; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 272360; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 283322; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 293675; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 298472; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 299164; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 300628; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 304910; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 306160; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 307347; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 311278; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 314508; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 322160; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 322686; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 345072; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 346879; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 351042; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 359697; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 360766; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 365636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 377095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 383414; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385957; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 399033; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 423307; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 100000593; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 298472; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 446247; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 101994; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 104403; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 51509; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62394; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 68585; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 86249; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 90304; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 95567; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259566; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 44095; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 54643; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 58148; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 76649; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 300628; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 345072; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 346879; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385381; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 193382; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 267616; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 124928; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 174867; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 70021; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 205443; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 62634; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 245111; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 168636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 214458; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 359697; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 365636; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 293675; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 185284; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 201660; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 351042; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 146848; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 259702; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 158427; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 120256; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 314508; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 148709; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 272360; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 114714; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 311278; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 399033; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 360766; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 137737; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 151248; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 385957; Model Number 09-1-012, UDI DI 00840113213412, Lot Number 249976; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 39949; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 46134; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 55036; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 56244; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 66210; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 71367; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 76618; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 78159; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 83547; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 87013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 091013; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 91598; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 94868; 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Model Number 09-1-013, UDI DI 00840113213474, Lot Number 154761; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 311412; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 273449; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 277747; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 380012; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 368437; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 279994; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 351041; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 176864; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 352886; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 185836; Model Number 09-1-013, UDI DI 00840113213474, Lot Number 367845; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 44507; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 48670; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 50630; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 52713; 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Model Number 09-1-014, UDI DI 00840113213573, Lot Number 122796; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 130784; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 136181; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 139121; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 141669; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 143118; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 144376; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 144377; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 148304; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 152382; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 157789; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 161614; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163211; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163211; Model Number 09-1-014, UDI DI 00840113213573, Lot Number 163521; Model Numbe