Blood pressure cuff bladder kits recalled for containing the wrong size bladder
Baxter Healthcare is recalling 118 Welch Allyn thigh replacement bladder kits because a kit may contain a Large Adult size bladder rather than a Thigh size bladder.
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: Scored 2 because the record cites the wrong bladder size supplied in a kit, with no stated consequence or reported harm.
Plain-English summary
The Welch Allyn INF BAG, Thigh 1-Tube, REF 5089-18, a replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff, is being recalled by Baxter Healthcare Corporation.
The replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder.
The recall covers 118 units carrying UDI-DI 00732094110845, across lot numbers including 23-296, 23-318, 23-325, 23-353, 24-008, 24-036, 24-037, 24-138 and 24-183. Distribution was nationwide in the United States, in California, Colorado, Ohio and Utah. The FDA has classified the action as Class II.
The record describes a size mismatch in the kit contents and does not state a further consequence or report injuries. Facilities should follow Baxter's instructions.
The recalled product
- Product
- Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 118
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 (14)
- UDI- DI 00732094110845
- Lot Numbers: 23-296
- 23-318
- 23-325
- 23-353
- 24-008
- 24-036
- 24-037
- 24-138
- 24-183
- 25-037
- 25-112
- 25-119
- 25-180
Distribution
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