CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report

C-Section Pack, Kit number 002643 recalled

Windstone Medical Packaging is recalling C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used, distributed nationwide in the US. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers/ Expiration Dates: 58207 8/31/2013 61591 1/2/2014 59228 1/19/2014 66522 1/31/2014 61763 3/5/2014 62929 9/10/2014 67485 9/19/2014 67664 9/21/2014 63835 9/22/2014 65290 9/30/2014 56956 6/18/2016 57666 6/23/2016 71060 10/13/2016 68943 10/26/2016 79065 11/9/2017 79842 1/25/2018 80908 2/15/2018

Quantity recalled268 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0159-2017
FDA event ID: 71968
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 20 Oct 2016
Reported: 26 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

22 Apr 2015	Recall initiated by company
20 Oct 2016	Classified by FDA	+547 days
26 Oct 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room

Where it was distributed

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Nationwide California Florida Georgia Illinois Kansas Louisiana Michigan New Jersey Nevada Texas Virginia Wyoming

Questions about this recall

Is C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used recalled?

Yes. Windstone Medical Packaging recalled C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0159-2017.

Why was it 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.

Which lots are affected?

Lot Numbers/ Expiration Dates: 58207 8/31/2013 61591 1/2/2014 59228 1/19/2014 66522 1/31/2014 61763 3/5/2014 62929 9/10/2014 67485 9/19/2014 67664 9/21/2014 63835 9/22/2014 65290 9/30/2014 56956 6/18/2016 57666 6/23/2016 71060 10/13/2016 68943 10/26/2016 79065 11/9/2017 79842 1/25/2018 80908 2/15/2018

Where was it sold?

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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