Custom Breast Augmentation Pack recall: Sterility Concern
Custom Breast Augmentation Pack, part number PSS2455(D
Why was Custom Breast Augmentation 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 100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/2017 89226, 5/25/2017 96139, 7/6/2017 96969, 7/30/2017 97625, 7/27/2017
- Product
- Custom Breast Augmentation Pack, part number PSS2455(D
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 229 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)