Reported Mar 8, 2017 · Terminated
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation…
Windstone Medical Packaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521
Is this the product you have?
- Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
- Lot codes and dates
Lot number and expiration date 1006349/23/2018 832416/20/2017 837576/1/2017 841741/14/2017 842491/20/2017 844966/21/2017 845213/19/2017 849044/28/2017 849101/25/2017 8507111/30/2017 851266/28/2017 851266/28/2017 851621/17/2017 855651/24/2017 856346/11/2017 858203/25/2017 858316/14/2017 859857/15/2017 860624/21/2017 861413/19/2017 866567/10/2017 867972/5/2018 868626/18/2017 870936/26/2017 871108/22/2017 877473/21/2017 885322/11/2018 890149/9/2017 8915512/22/2017 8924412/13/2017 8956912/3/2017 897705/3/2017 899327/7/2017 946015/16/2017 951847/29/2017 951855/12/2017 952245/1/2017 952653/20/2018 956239/22/2017 9579312/1/2017 962995/22/2019 965633/28/2018 969875/21/2017 9756312/22/2017 975643/30/2018 979022/9/2018 984363/7/2018 9844512/25/2018 989002/28/2018 989379/12/2018 989802/3/2018 992583/8/2018
- Amount recalled
- 1436 kits
This recall covers 124 products
The agency filed one notice per product. You are reading one of them; the other 123 are below.
111 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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