Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 112051996 112114535 113025779 113078335 113099443 140111073 140412695 140613606 140714299
- 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 products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Product Codes/Lot Numbers:
Lot numbers: 112051996 112114535 113025779 113078335 113099443 140111073 140412695 140613606 140714299
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0248-2015
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.