[pending] Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder f
Pending LLM rewrite. Source: FDA_DEVICE Z-0847-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
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 in the replacement kits.
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
- Category
- Medical Device — Devices
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
Distributed nationwide across the United States.
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