The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0098-2013·Announced 2012-10-31

Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Westmed Inc is recalling Pulset Arterial Blood Gas (ABG) sampling kits, part number 3173-14. These kits are used to obtain arterial blood samples from patients for blood gas determinations. The recall involves 1,259,200 units distributed nationwide in the United States and in Canada, El Salvador, the United Arab Emirates, Holland, Costa Rica, and Lebanon.

The recall is being conducted because the kits contain TRIAD brand alcohol pads. TRIAD is separately recalling these alcohol pads due to potential contaminants. The specific lot numbers affected by this recall are 38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, and 48073.

Healthcare providers and consumers should stop using these specific kits and contact Westmed Inc for instructions on how to return the product or obtain a replacement.

The recalled product

Product
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…
Manufacturer
Westmed Inc
Affected units
1,259,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Westmed Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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