LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %" (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15" X 20" L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8" STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8" STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP 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 900-1688, 16 lots: 112114380 112114643 113036740 113047004 113057426 113068154 113088751 113099276 131110193 140211464 140211704 140311926 140312434 140412555 140513103 140513462
- 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 - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %" (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15" X 20" L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8" STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8" STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1688, 16 lots: 112114380 112114643 113036740 113047004 113057426 113068154 113088751 113099276 131110193 140211464 140211704 140311926 140312434 140412555 140513103 140513462
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2404-2014
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.