PlainRecalls
FDA Devices Moderate Class II Terminated

Set-Up Pack, part number PSS1305(C

Reported: March 8, 2017 Initiated: January 11, 2017 #Z-1367-2017

Product Description

Set-Up Pack, part number PSS1305(C

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
1275 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?
Set-Up Pack, part number PSS1305(C. Recalled by Windstone Medical Packaging, Inc.. Units affected: 1275 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-1367-2017.