Endoscopy Pack recall: Sterility Concern
Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
Why was Endoscopy 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: 59053 3/28/2015 77459 9/11/2015 65230 10/26/2015 60259 10/27/2015 61170 11/14/2015 66914 11/26/2015 64387 1/11/2016 63883 1/25/2016 57221 6/19/2016 57956 7/20/2016 77460 7/30/2016 69800 9/6/2016 70560 12/3/2016 72104 1/1/2017 72585 4/19/2017
- Product
- Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 304 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)