Ortho Pack recall: Sterility Concern
Ortho Pack, part number PSS3466(A
Why was Ortho 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 88900, 10/10/2018 94563, 1/4/2019 95875, 1/6/2019 96652, 3/8/2019 97170, 5/5/2019 98072, 5/1/2019 98589, 10/12/2019
- Product
- Ortho Pack, part number PSS3466(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 84 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)