O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42" X 75" CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41" X 58" SMS LIF 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 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626
- 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:
O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1) GOWN LARGE SMS IMPERVIOUS REINFORCED (3) TOWELS ABSORBENT 15" X 20" LIF (I) PAD OBSTETRICAL X-LARGE ST. (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (I) UMBILICAL CORD CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz. LIF (I) COVER SET UP 42" X 75" CLEARPOLY (1) DRAPE ABDOMINAL WITH TAPE L/F (1) BOWL WITH LID PLASTICS 80oz. L/F (1) SHEET DRAPE 41" X 58" SMS LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2407-2014
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.