🔍 RecallPedia

ANGIOGRAPHY PACK CUSTOMED 4/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:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16
  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:

ANGIOGRAPHY PACK CUSTOMED 4/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:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2622-2015

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