Reported Oct 26, 2016 · Terminated
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B.…
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?
- Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
- Lot codes and dates
- Lot Number/ Expiration Date
106 of 106 codes
590078/27/2013576108/31/20136012812/15/20136209912/21/2013612972/9/2014621892/12/2014575224/30/2014600285/12/2014603035/19/2014614168/17/2014638369/7/2014667999/19/20146192412/3/20146333312/8/20146516712/31/2014673692/4/2015680734/17/2015709839/6/2015701699/21/20157106110/10/20156533111/5/20156208211/7/20156658011/20/2015645441/29/2016689472/19/2016748543/23/2016755344/25/2016696105/7/2016713526/17/2016666777/5/2016
- Lot Number/ Expiration Date
- Amount recalled
- 1124 kits
This recall covers 150 products
The agency filed one notice per product. You are reading one of them; the other 149 are below.
137 more are in the archive.
Where it was sold
Why it was recalled
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit 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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