Lower Extremity Pack recall: Sterility Concern
Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating…
Why was Lower Extremity 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: 62895 3/16/2014 61290 3/30/2014 57472 4/2/2014 59889 8/8/2014 61313 8/27/2014 62201 10/18/2014 63202 12/12/2014 64163 12/17/2014 65489 3/8/2015 68367 4/13/2015 66793 4/30/2015 69272 9/14/2015 70920 9/30/2015 71438 11/4/2015 66044 11/8/2015 64134 11/10/2015 65690 11/17/2015 71985 11/30/2015 65282 12/1/2015 68490 12/21/2015 69186 12/21/2015 71052 12/25/2015 67699 12/27/2015 67960 12/30/2015 72484 5/28/2016 69442 9/21/2016 80467 10/31/2016
- Product
- Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 582 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)