CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP 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: Code 900-2899, 2 lots 140111333 140412673
- 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 BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Code 900-2899, 2 lots 140111333 140412673
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2508-2014
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.