FDAClass IIOctober 26, 2016

General Plastic Pack recall: Sterility Concern

General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital…

Why was General Plastic 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: 66206 2/25/2015 61424 8/18/2015 63370 11/2/2015 58543 11/8/2015 65418 11/9/2015 63596 11/11/2015 61749 11/22/2015 63420 1/4/2016 64414 1/9/2016 64968 1/13/2016 56888 5/22/2016 56889 5/23/2016 57341 6/8/2016 68248 7/11/2016 58351 7/14/2016 67619 7/16/2016 67417 8/9/2016 57586 8/14/2016 70741 9/5/2016 70742 9/5/2016 68659 9/21/2016 69502 9/23/2016 70631 9/24/2016 69732 9/26/2016 69073 9/27/2016 68295 9/28/2016 68059 9/29/2016 70630 10/23/2016 71024 12/10/2016 71126 12/17/2016 72093 1/7/2017 70999 1/18/2017 73785 1/27/2017 73806 4/5/2017 73807 4/9/2017 74111 4/10/2017 73618 4/20/2017 76130 7/15/2017 81087 1/9/2018

Product
General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
1378 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