FDAClass IIOctober 26, 2016

Podiatry Kit PSS1040(A recall: Sterility Concern

Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room

Why was Podiatry Kit PSS1040(A 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 Number/ Expiration Date: 63877 2/4/2015 65406 2/26/2015 65972 2/26/2015 64947 10/18/2015 61767 11/13/2015 64379 1/4/2016 63309 1/22/2016 57497 7/1/2016 67411 7/11/2016 58086 7/19/2016 77189 7/30/2016 68577 9/22/2016 69473 10/17/2016 72803 1/16/2017 72989 3/29/2017 73422 4/16/2017 76920 4/23/2017 73577 4/25/2017 74415 5/9/2017 74835 6/18/2017 76482 7/13/2017

Product
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
545 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