Breast Pack recall: Sterility Concern
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom…
Why was Breast 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: 59572 3/1/2015 58932 4/24/2015 57078 7/8/2015 57694 7/14/2015 60620 8/4/2015 61768 11/4/2015 67414 11/16/2015 65034 1/17/2016 75189 4/16/2016 76805 4/17/2016 57372 6/19/2016 57636 6/20/2016 66625 7/29/2016 67295 9/27/2016 71082 9/28/2016 71404 12/21/2016 72826 1/16/2017 72162 1/27/2017 75661 6/18/2017 76889 7/16/2017 77066 7/19/2017 81026 1/13/2018 79638 1/9/2019
- Product
- Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 505 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)