Shoulder Arthroscopy Pack recall: Sterility Concern
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for…
Why was Shoulder Arthroscopy 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 Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018
- Product
- Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1124 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)