PlainRecalls
FDA Devices Moderate Class II Terminated

Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A

Reported: March 8, 2017 Initiated: January 11, 2017 #Z-1341-2017

Product Description

Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(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
665 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?
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A. Recalled by Windstone Medical Packaging, Inc.. Units affected: 665 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-1341-2017.