CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report

Pulset Arterial Blood Gas (ABG) sampling kit recalled by Westmed

Westmed is recalling Pulset Arterial Blood Gas (ABG) sampling kit, distributed nationwide in the US. The recall was initiated on 18 Jan 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073,
Quantity recalled1,259,200 units total

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-0098-2013
FDA event ID
63276
Recalling firm
Westmed, Tucson, AZ
Classification
Class II
Status
Terminated
Recall initiated
18 Jan 2011
FDA classified
20 Oct 2012
Reported
31 Oct 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

18 Jan 2011Recall initiated by company
20 Oct 2012Classified by FDA+641 days
31 Oct 2012Published in enforcement report+11 days

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

Reason for recall

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Product as listed by the FDA

Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.

Nationwide

Questions about this recall

Why was it recalled?

Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

Which lots are affected?

Lot Numbers: 38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073,

Where was it sold?

Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.

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.

Other products in this recall event

13 other products · FDA event 63276

This product is part of a recall event; the main page for the event is Pulset Arterial Blood Gas (ABG) sampling kit recalled by Westmed.

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