Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling Pulset ABG sampling kits because they contain TRIAD 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 involves a medical device with a risk of harm due to potential contaminants, but the source text does not report any illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Westmed Inc is recalling Pulset Arterial Blood Gas (ABG) sampling kits, part number 3372. 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 specific alcohol pads due to the presence of potential contaminants. The source text does not specify the nature of the contaminants or report any illnesses or injuries associated with the use of these kits.
Consumers and healthcare facilities should stop using the affected kits. The affected lot numbers are 38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, and 4669149785.
The recalled product
- Product
- Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
- 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 (16)
- Lot Numbers: 38941
- 39213
- 40203
- 41694
- 42317
- 42700
- 43129
- 43195
- 43502
- 44695
- 45065
- 45254
- 45919
- 46776
- 47369
- 4669149785.
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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