FDAClass IIOctober 26, 2016

Abdominoplasty Tray recall: Sterility Concern

Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating…

Why was Abdominoplasty Tray recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom 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: 62789 11/7/2015 61201 11/8/2015 63413 11/9/2015 67096 11/9/2015 64598 1/29/2016 74803 6/26/2016 57510 6/27/2016 67607 8/21/2016 69801 9/15/2016 71002 10/6/2016 68446 10/9/2016 71403 12/24/2016 72095 1/14/2017 78759 11/5/2017 81077 2/13/2018

Product
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
192 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