Suction Catheter Kit, Catalog number 900-277. 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: 111113095 111123232 112010156 112020472 112030761 112041313 112062452 112072959 112082969 112083427 112104362 112114536 112124889 113026115 113036350 113036799 113047312 113068166 113109823 131110258 131210686 140312144 140412667 140513046 140613603 140714263 140814789 140915159
- 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:
Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Product Codes/Lot Numbers:
Lot numbers: 111113095 111123232 112010156 112020472 112030761 112041313 112062452 112072959 112082969 112083427 112104362 112114536 112124889 113026115 113036350 113036799 113047312 113068166 113109823 131110258 131210686 140312144 140412667 140513046 140613603 140714263 140814789 140915159
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0243-2015
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.