PlainRecalls
FDA Devices Moderate Class II Terminated

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Ext

Reported: March 8, 2017 Initiated: January 11, 2017 #Z-1295-2017

Product Description

Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A

Reason for Recall

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.

Details

Units Affected
810 kits
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Location
Billings, MT

Frequently Asked Questions

What product was recalled?
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A. Recalled by Windstone Medical Packaging, Inc.. Units affected: 810 kits.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1295-2017.