PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344
- 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:
PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP
Product Codes/Lot Numbers:
Product code 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2384-2014
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.