Open Procedure Pack II recall: Sterility Concern
Open Procedure Pack II, part number RMS1740(A
Why was Open Procedure Pack II 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 84814, 2/6/2018 86168, 8/30/2018 88510, 12/1/2018 89151, 1/21/2019 95032, 1/13/2019 96555, 6/1/2019 98134, 6/6/2019 99502, 9/17/2019
- Product
- Open Procedure Pack II, part number RMS1740(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 160 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)