CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F 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 900-430, 29 lots: 110020453 110030667 110051146 111030671 111040897 111061672 111071814 111082217 111092389 111102877 111113116 111123253 112010174 112030874 112041411 112072872 112083431 113015513 113015697 113036365 113047211 113057626 113078328 113088864 113109841 131110304 140111229 140312164 140412467
- 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:
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7" CUFF 30" X 42" LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH 44" X 35" LIF (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF (1) TUR Y SET 81 "2.1 M REGULAR CLAM (4) GAUZE SPONGES 4" X 4" 12 PLY XRD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Product Codes/Lot Numbers:
Product code 900-430, 29 lots: 110020453 110030667 110051146 111030671 111040897 111061672 111071814 111082217 111092389 111102877 111113116 111123253 112010174 112030874 112041411 112072872 112083431 113015513 113015697 113036365 113047211 113057626 113078328 113088864 113109841 131110304 140111229 140312164 140412467
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2325-2014
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.