HSG Pack recall: Sterility Concern
HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
Why was HSG 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: 67433 8/1/2016 71250 9/12/2016 69748 9/20/2016 71417 1/3/2017 72802 4/23/2017 74796 7/14/2017 78203 8/5/2017 76919 8/16/2017 79432 2/25/2018
- Product
- HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 360 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)