Device product
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42" (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" (4) DRAPE UTILITY WITH TAPE (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) CONNECTING TUBING 3/16" X 12" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Z-2337-2014
Product summary
- Firm
- Customed, Inc
- Event
- Event 68536
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24 lots; 648 units (multiple units per lot)
- Official record key
device-enforcement:Z-2337-2014
Official wording
Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Code information: Product code 900-618, 24 lots: 109010109 109030609 109040846 109051047 109061208 109071536 109071688 109092073 109102337 112020491 112030732 112051999 112062499 112083436 112093647 113036805 113057495 113057617 113078338 113088878 113099446 113109861 140211734 140312178
Distribution pattern: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Derived failure modes
-
Labeling or packaging
packaging integrity may be compromised
-
Sterility assurance
loss of sterility