Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads
Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.
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 potential contaminant hazard where no injuries or illnesses have been reported, fitting the rubric 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, specifically the Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin (part number 3165-98). The recall involves 1,259,200 units that were 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, which are being recalled by TRIAD due to 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.
Healthcare providers and consumers should stop using these specific kits and contact Westmed Inc for further instructions or a replacement.
The recalled product
- Product
- Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood…
- 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 (1)
- not available
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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