LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44" X 90" (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code 900-1059, 16 lots: 112030823 113047111 113057410 113057823 113078454 113078566 113099561 113109983 131110149 131110397 131110577 131210955 140211914 140312430 140513062 140513474
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Customed, Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44" X 90" (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1059, 16 lots: 112030823 113047111 113057410 113057823 113078454 113078566 113099561 113109983 131110149 131110397 131110577 131210955 140211914 140312430 140513062 140513474
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2369-2014
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.