Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Arterial Blood Gas (ABG) 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with potential contaminants, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Westmed Inc is recalling Pulset Arterial Blood Gas (ABG) sampling kits, part number 3373-95. The recall is being conducted because the kits contain TRIAD brand alcohol pads, which are subject to a separate recall due to potential contaminants.
The affected products are the Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin. A total of 1,259,200 units were distributed worldwide, including the United States, Canada, El Salvador, United Arab Emirates, Holland, Costa Rica, and Lebanon. The recall covers specific lot numbers listed in the agency record.
This is an FDA Class II recall. No specific illnesses or injuries are reported in the source text. Healthcare providers and consumers should stop using the affected kits and contact Westmed for further instructions.
The recalled product
- Product
- Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. 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
- Hazard
- 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 (20)
- Lot Numbers: 38784
- 39142
- 39144
- 39145
- 39211
- 39137
- 39141
- 39322
- 39321
- 39629
- 39628
- 39630
- 39830
- 39831
- 39832
- 40424
- 40625
- 40950
- 41402
- 41415
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.
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