Recall record at a glance
| Official record | Z-1567-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Baxter Healthcare Corporation |
| Report date | Apr 23, 2025 |
| Recall initiation date | Mar 21, 2025 |
| Quantity | 385920 units |
| Location | Deerfield, IL, United States |
Official product description
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.
Why the product was recalled
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Distribution information
Worldwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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