PlainRecalls
FDA Devices Moderate Class II Terminated

Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room

Reported: October 26, 2016 Initiated: April 22, 2015 #Z-0211-2017

Product Description

Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A 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
N/A
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?
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room. Recalled by Windstone Medical Packaging, Inc.. Units affected: N/A.
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-0211-2017.