🔍 RecallPedia

LAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Class I - Dangerous
🏥 Medical Devices Recalled: July 10, 2015 Customed Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Code:900281A Lots: 140814951 exp. 2/28/16 140714543 exp. 2/28/16 141015713 exp. 10/31/15 150116503 exp. 12/31/15 150116513 exp. 12/31/15 150116514 exp. 12/31/15 150116515 exp. 12/31/15 141216437 exp. 12/31/15 150116939 exp. 2/28/16 150116940 exp. 2/28/16 150116938 exp. 2/28/16 150116941 exp. 2/28/16 150116937 exp. 2/28/16 150317732 exp. 3/31/16 150317731 exp. 3/3/16 150317734 exp. 3/31/16 150317733 exp. 3/31/16 150317954 exp. 4/30/16 150317957 exp. 4/30/16 150317958 exp. 4/30/16 150317959 exp. 4/30/16 150317960 exp. 4/30/16 150317961 exp. 4/30/16 150418383 exp. 4/30/16 150418384 exp. 4/30/16 150418385 exp. 4/30/16 150518790 exp. 5/31/16 150519028 exp. 5/31/16 150519029 exp. 5/31/16
  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:

LAPAROTOMY SURGICAL PACK 3/CS 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:

Code:900281A Lots: 140814951 exp. 2/28/16 140714543 exp. 2/28/16 141015713 exp. 10/31/15 150116503 exp. 12/31/15 150116513 exp. 12/31/15 150116514 exp. 12/31/15 150116515 exp. 12/31/15 141216437 exp. 12/31/15 150116939 exp. 2/28/16 150116940 exp. 2/28/16 150116938 exp. 2/28/16 150116941 exp. 2/28/16 150116937 exp. 2/28/16 150317732 exp. 3/31/16 150317731 exp. 3/3/16 150317734 exp. 3/31/16 150317733 exp. 3/31/16 150317954 exp. 4/30/16 150317957 exp. 4/30/16 150317958 exp. 4/30/16 150317959 exp. 4/30/16 150317960 exp. 4/30/16 150317961 exp. 4/30/16 150418383 exp. 4/30/16 150418384 exp. 4/30/16 150418385 exp. 4/30/16 150518790 exp. 5/31/16 150519028 exp. 5/31/16 150519029 exp. 5/31/16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2657-2015

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