General Plastics Pack recall: Sterility Concern
General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
Why was General Plastics 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: 60558 11/6/2014 58503 11/9/2014 58887 11/15/2014 61480 11/21/2014 61881 5/16/2015 62122 5/25/2015 72125 3/12/2016 56859 5/22/2016 57574 6/26/2016 75367 10/18/2016 78105 10/20/2016 72126 10/21/2016 73669 10/23/2016 74705 10/23/2016 72127 10/27/2016 76745 4/2/2017 75824 4/23/2017 79786 8/6/2017
- Product
- General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 985 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)