FDAClass IIMarch 8, 2017

Peri GYN recall: Sterility Concern

Peri GYN, part number PSS2193(A

Why was Peri GYN 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number and expiration date 86291, 9/19/2017 87829, 10/7/2017 96967, 4/21/2018 98214, 6/19/2018 99585, 9/28/2018

Product
Peri GYN, part number PSS2193(A
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
120 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.
Recall date
March 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls