LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1) BLADE SURGICAL #11 S/STEEL (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH (4) DRAPE UTILITY WITH TAPE UF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F (1) TROCAR DILATING XCEL 5MM x 100 (D5LT) (1) TROCAR ENDO.XCEL DILATING TIP 11MM (1) SUTURE BAG FLORAL UF (1) CLOSURE SKIN W' X 4" STERI STRIP LF 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 900-1803, 7 lots: 112114857 112125169 113026230 113036759 140312276 140412556 140513115
- 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 PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1) BLADE SURGICAL #11 S/STEEL (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF (1) MAYO STAND COVER REINFORCED UF (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH (4) DRAPE UTILITY WITH TAPE UF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F (1) TROCAR DILATING XCEL 5MM x 100 (D5LT) (1) TROCAR ENDO.XCEL DILATING TIP 11MM (1) SUTURE BAG FLORAL UF (1) CLOSURE SKIN W' X 4" STERI STRIP LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1803, 7 lots: 112114857 112125169 113026230 113036759 140312276 140412556 140513115
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2413-2014
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.