Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers/ Expiration Dates: 58460 7/10/2015 60260 7/18/2015 61708 10/14/2015 65115 11/17/2015 61937 11/29/2015 64687 1/12/2016 68445 3/17/2016 66915 7/5/2016 57957 7/21/2016 67620 9/29/2016 70297 10/26/2016 73096 11/12/2016 72508 11/21/2016 73565 12/20/2016 74851 1/23/2017 75802 4/30/2017 79176 5/5/2017 79475 5/26/2017 79793 6/27/2017
  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:
Windstone Medical Packaging, Inc.
Reason for Recall:
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Numbers/ Expiration Dates: 58460 7/10/2015 60260 7/18/2015 61708 10/14/2015 65115 11/17/2015 61937 11/29/2015 64687 1/12/2016 68445 3/17/2016 66915 7/5/2016 57957 7/21/2016 67620 9/29/2016 70297 10/26/2016 73096 11/12/2016 72508 11/21/2016 73565 12/20/2016 74851 1/23/2017 75802 4/30/2017 79176 5/5/2017 79475 5/26/2017 79793 6/27/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0179-2017

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