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.
What this means for you
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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