FDAClass IIOctober 26, 2016

C-Tray Pack recall: Sterility Concern

C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room

Why was C-Tray Pack 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: 59927 1/26/2013 67573 1/15/2014 65388 1/17/2014 66189 1/18/2014 64668 1/25/2014 68256 12/6/2014 72518 7/8/2015 75168 7/16/2015 73464 7/17/2015 77622 1/26/2016 76003 7/3/2016 77246 7/17/2016 76580 7/29/2016 74412 7/31/2016 72288 1/9/2017

Product
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
186 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