Laparotomy Pack recall: Sterility Concern
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery…
Why was Laparotomy Pack recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers/Expiration dates: 57968 3/10/2014 58335 3/26/2014 57096 3/30/2014 59915 6/16/2014 58966 6/19/2014 61731 8/7/2014 63240 8/21/2014 61024 9/17/2014 61499 9/22/2014 63588 2/11/2015 65772 2/25/2015 65779 2/26/2015 64225 2/28/2015 65239 3/20/2015 66645 7/20/2015 68070 8/4/2015 58830 8/5/2015 68893 8/12/2015 68265 8/17/2015 59541 8/30/2015 60650 9/1/2015 69806 10/6/2015 59840 11/9/2015 63811 1/18/2016 73766 2/2/2016 72807 2/7/2016 71917 2/9/2016 73424 2/15/2016 72515 2/15/2016 73401 2/15/2016 72806 2/28/2016 74679 4/11/2016 74853 5/15/2016 71892 6/1/2016 74680 6/1/2016 71726 6/11/2016 72656 6/16/2016 57461 6/23/2016 57174 7/11/2016 58034 7/11/2016 76085 8/4/2016 58492 8/8/2016 58502 8/13/2016 76923 8/24/2016 78168 9/5/2016 79609 9/9/2016 78573 9/27/2016 70930 9/28/2016 71324 10/19/2016 73071 1/29/2017 74331 5/1/2017 75004 5/4/2017 75545 7/16/2017 77174 7/20/2017 79653 8/7/2017 78409 8/12/2017 79636 1/9/2019
- Product
- Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1528 kits
- Distribution
- Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)