Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    LOTS: SL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-16
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Product Codes/Lot Numbers:

LOTS: SL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1450-2016

Related Recalls