Plastic Kit, Kit number CMP1084(B 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 Number/ Expiration Date: 58302 3/26/2014 59046 6/9/2014 60228 6/15/2014 60559 6/20/2014 63222 8/14/2014 61004 9/13/2014 61491 9/21/2014 63003 12/11/2014 64005 2/14/2015 63768 2/22/2015 64592 3/18/2015 65494 5/30/2015 67289 6/11/2015 67602 8/14/2015 68438 8/22/2015 68275 8/25/2015 69589 10/22/2015 70504 10/24/2015 71258 12/7/2015 71749 12/19/2015 72506 2/15/2016 72750 2/22/2016 74081 2/24/2016 73436 2/28/2016 56986 5/24/2016 76902 6/20/2016 77188 9/9/2016 77986 9/18/2016 78514 9/19/2016 79246 9/26/2016 80549 10/27/2016
  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:

Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot Number/ Expiration Date: 58302 3/26/2014 59046 6/9/2014 60228 6/15/2014 60559 6/20/2014 63222 8/14/2014 61004 9/13/2014 61491 9/21/2014 63003 12/11/2014 64005 2/14/2015 63768 2/22/2015 64592 3/18/2015 65494 5/30/2015 67289 6/11/2015 67602 8/14/2015 68438 8/22/2015 68275 8/25/2015 69589 10/22/2015 70504 10/24/2015 71258 12/7/2015 71749 12/19/2015 72506 2/15/2016 72750 2/22/2016 74081 2/24/2016 73436 2/28/2016 56986 5/24/2016 76902 6/20/2016 77188 9/9/2016 77986 9/18/2016 78514 9/19/2016 79246 9/26/2016 80549 10/27/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0262-2017

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The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

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