PlainRecalls
FDA Devices Moderate Class II Terminated

Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room

Reported: October 26, 2016 Initiated: April 22, 2015 #Z-0183-2017

Product Description

Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room

Reason for Recall

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.

Details

Units Affected
3829 kits
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Location
Billings, MT

Frequently Asked Questions

What product was recalled?
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room. Recalled by Windstone Medical Packaging, Inc.. Units affected: 3829 kits.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0183-2017.