CLASS II Device recall · Reported 16 Dec 2015 · FDA Enforcement Report

AMS 4674 Custom Pack recalled by Windstone Medical Packaging

Windstone Medical Packaging is recalling AMS 4674 Custom Pack, distributed in Alabama, Virginia. The recall was initiated on 2 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 84370, expiration date: 2/28/2017

Quantity recalled40 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-0376-2016
FDA event ID: 72604
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2015
FDA classified: 4 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Nov 2015	Recall initiated by company
4 Dec 2015	Classified by FDA	+32 days
16 Dec 2015	Published in enforcement report	+12 days

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

Reason for recall

AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Product as listed by the FDA

AMS 4674 Custom Pack. For use in a general clinical procedure.

Where it was distributed

Distributed in AL and VA.

Alabama Virginia

Questions about this recall

Why was it recalled?

AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Which lots are affected?

Lot 84370, expiration date: 2/28/2017

Where was it sold?

Distributed in AL and VA.

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

Other products in this recall event

1 other product · FDA event 72604

This product is part of a recall event; the main page for the event is AMS 4675 Angio Pack recalled by Windstone Medical Packaging.

Reported	Class	Recall	Company	Reason	Where
16 Dec 2015	CLASS II	AMS 4675 Angio Pack recalled by Windstone Medical Packaging	Windstone Medical Packaging	Other	AL, VA

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