Major Kit recall: Sterility Concern
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Why was Major Kit 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 59849 9/7/2015 65027 10/19/2015 62205 11/5/2015 57300 7/1/2016 77646 7/30/2016 66323 8/27/2016 73020 1/29/2017 70214 1/30/2017 75780 7/8/2017
- Product
- Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 175 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)