Peri GYN recall: Sterility Concern
Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
Why was Peri GYN 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: 58336 3/5/2014 61990 8/20/2014 61732 9/10/2014 63878 2/9/2015 65773 2/25/2015 64610 3/27/2015 68071 8/5/2015 69931 10/26/2015 71918 2/15/2016 73291 2/22/2016 74558 6/14/2016 77064 7/14/2016 78767 9/5/2016 78000 9/8/2016
- Product
- Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 430 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)