🔍 RecallPedia

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

Class I - Dangerous
🏥 Medical Devices Recalled: April 22, 2015 Windstone Medical Packaging Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115 5/10/2016 75128 5/17/2016 75800 5/22/2016 56502 5/23/2016 56722 5/30/2016 57013 6/7/2016 56723 6/12/2016 57469 6/18/2016 57573 6/27/2016 71877 7/2/2016 71435 7/4/2016 66796 7/5/2016 57790 7/8/2016 57774 7/9/2016 71073 7/13/2016 66551 7/14/2016 71879 7/15/2016 58288 7/16/2016 57645 7/17/2016 77366 7/17/2016 57945 7/18/2016 71437 7/18/2016 71982 7/22/2016 69061 7/26/2016 71268 7/26/2016 71981 7/29/2016 78379 7/29/2016 77328 7/30/2016 78043 7/30/2016 78160 7/30/2016 58451 7/31/2016 58067 8/2/2016 71436 8/5/2016 67206 8/11/2016 58275 8/14/2016 58587 8/30/2016 78339 8/31/2016 75047 9/2/2016 79834 10/12/2016 81141 10/31/2016 78837 11/5/2016 80914 11/6/2016 60593 11/26/2016 77334 7/20/2017 76451 7/22/2017 77342 10/1/2017
  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:

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

Product Codes/Lot Numbers:

Lot codes/Expiration dates: 65013 3/1/2014 58261 3/20/2014 58964 3/27/2014 61857 4/10/2014 60968 4/20/2014 57095 4/25/2014 59002 5/2/2014 60388 5/5/2014 60299 6/30/2014 62798 8/21/2014 62654 10/25/2014 64447 12/5/2014 63072 12/9/2014 64328 12/13/2014 64679 12/18/2014 63368 12/20/2014 63799 1/13/2015 66644 2/2/2015 66509 2/14/2015 65777 2/25/2015 65573 2/25/2015 65718 2/28/2015 65875 3/6/2015 65572 3/15/2015 59027 3/26/2015 58692 4/5/2015 68613 4/12/2015 67175 4/14/2015 57249 4/20/2015 68069 4/28/2015 59297 7/3/2015 59538 7/4/2015 59157 7/13/2015 59846 8/2/2015 60663 8/4/2015 60131 8/5/2015 60113 8/6/2015 60132 8/6/2015 70171 8/13/2015 61311 8/18/2015 61435 8/20/2015 59514 8/24/2015 59845 8/31/2015 60605 9/7/2015 60754 9/7/2015 61006 9/7/2015 60722 9/11/2015 61164 9/14/2015 60662 9/20/2015 61479 9/21/2015 68892 9/29/2015 61310 10/16/2015 65295 11/2/2015 71133 11/2/2015 62199 11/5/2015 62600 11/5/2015 62349 11/6/2015 61601 11/6/2015 64476 11/6/2015 66318 11/6/2015 61521 11/7/2015 66319 11/8/2015 65296 11/10/2015 64850 11/11/2015 64477 11/11/2015 62200 11/13/2015 62943 11/13/2015 70754 11/13/2015 62903 11/14/2015 63199 11/15/2015 61602 11/23/2015 61642 11/26/2015 62425 11/27/2015 62546 11/27/2015 66795 11/27/2015 61603 11/29/2015 65598 11/30/2015 65700 11/30/2015 72347 12/4/2015 72783 12/15/2015 72804 12/21/2015 65699 12/23/2015 65294 12/26/2015 65195 12/27/2015 64632 1/2/2016 73047 1/6/2016 64291 1/7/2016 64349 1/8/2016 63430 1/9/2016 65019 1/12/2016 64475 1/16/2016 63200 1/18/2016 63711 1/22/2016 63948 1/25/2016 64042 1/30/2016 63984 1/30/2016 67589 2/5/2016 69258 2/5/2016 69459 2/5/2016 71210 2/11/2016 66794 2/14/2016 68862 2/14/2016 69603 2/20/2016 69604 2/20/2016 67588 2/24/2016 74530 2/25/2016 73860 3/6/2016 74555 3/10/2016 68572 3/13/2016 68863 3/22/2016 69062 3/26/2016 66552 4/4/2016 70511 4/6/2016 71878 4/8/2016 70512 4/10/2016 70267 4/14/2016 70268 4/16/2016 74731 4/18/2016 69605 4/20/2016 69866 4/23/2016 70510 4/24/2016 73286 4/24/2016 74443 4/25/2016 77115 5/10/2016 75128 5/17/2016 75800 5/22/2016 56502 5/23/2016 56722 5/30/2016 57013 6/7/2016 56723 6/12/2016 57469 6/18/2016 57573 6/27/2016 71877 7/2/2016 71435 7/4/2016 66796 7/5/2016 57790 7/8/2016 57774 7/9/2016 71073 7/13/2016 66551 7/14/2016 71879 7/15/2016 58288 7/16/2016 57645 7/17/2016 77366 7/17/2016 57945 7/18/2016 71437 7/18/2016 71982 7/22/2016 69061 7/26/2016 71268 7/26/2016 71981 7/29/2016 78379 7/29/2016 77328 7/30/2016 78043 7/30/2016 78160 7/30/2016 58451 7/31/2016 58067 8/2/2016 71436 8/5/2016 67206 8/11/2016 58275 8/14/2016 58587 8/30/2016 78339 8/31/2016 75047 9/2/2016 79834 10/12/2016 81141 10/31/2016 78837 11/5/2016 80914 11/6/2016 60593 11/26/2016 77334 7/20/2017 76451 7/22/2017 77342 10/1/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0204-2017

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