Lithotomy Pack recall: Sterility Concern
Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
Why was Lithotomy 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: 61276 3/4/2014 61277 3/10/2014 62761 11/15/2015 64641 11/30/2015 65276 11/30/2015 69772 12/3/2015 71457 12/3/2015 68312 12/5/2015 69392 12/17/2015 71152 12/17/2015 68629 12/25/2015 64905 12/27/2015
- Product
- Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 630 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)