FDAClass IIOctober 26, 2016

Peri Kit recall: Sterility Concern

Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room

Why was Peri Kit 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.

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 Numbers/ Expiration Dates: 57953 7/20/2016 58914 9/12/2015 61492 11/7/2015 62258 11/20/2015 63415 1/22/2016 63988 11/22/2015

Product
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
115 kits
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls