Reported Mar 8, 2017 · Terminated
Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker…
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?
Pacemaker Kitpart number AMS4281 Pacemaker Kitpart number AMS4281(A Pacemaker Kitpart number AMS4281(C Pacemaker Kitpart number AMS4281(D
- Lot codes and dates
Lot number and expiration date 804925/3/2018 825026/8/2018 853027/12/2018 8815311/13/2018 8911612/10/2018 8931811/22/2018 950701/29/2019 9508811/14/2018 955801/4/2019 955811/4/2019 955821/11/2019 955831/24/2019 971156/12/2019
- Amount recalled
- 561 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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