Laminectomy Pack recall: Sterility Concern
Laminectomy Pack, part number PSS1844(B
Why was Laminectomy Pack recalled?
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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 number and expiration date 83287, 8/9/2017 87158, 7/10/2017 88004, 10/5/2017 88548, 10/14/2017 89055, 11/16/2017 89903, 12/28/2017 95142, 2/12/2018 95314, 2/9/2018 95839, 2/12/2018 96468, 3/26/2018 96630, 4/11/2018 96820, 6/12/2018 98748, 10/20/2017 99774, 6/24/2018
- Product
- Laminectomy Pack, part number PSS1844(B
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 291 kits
- Distribution
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Recall date
- March 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)