CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: 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 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462
- 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 differ 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:
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-2005, 14 lots: 111123199 112030704 112041279 112051918 112083420 112125056 113036459 113047202 113057860 113078296 113088780 113109780 140211726 140412462
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2430-2014
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.