Recall record at a glance
| Official record | Z-1509-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Baxter Healthcare Corporation |
| Report date | Apr 17, 2024 |
| Recall initiation date | Mar 26, 2024 |
| Quantity | 11154 units |
| Location | Deerfield, IL, United States |
Official product description
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOTH, MOBILE, UK, Product Code 34BXST-4; f) PROBP 3400, BLUETOOTH, MOBILE, ZA, Product Code 34BXST-7; g) PROBP 3400, SUREBP, MOBILE, EU, Product Code 34XFST-2; h) PROBP 3400, SUREBP, MOBILE, UK, Product Code 34XFST-4; i) PROBP 3400, SUREBP, MOBILE, AU, Product Code 34XFST-6; j) PROBP 3400, SUREBP, MOBILE, ZA, Product Code 34XFST-7; k) PROBP 3400, MOBILE, EU, Product Code 34XXST-2; l) PROBP 3400, MOBILE, UK, Product Code 34XXST-4; m) PROBP 3400, MOBILE, AU, Product Code 34XXST-6; n) PROBP 3400, MOBILE, ZA, Product Code 34XXST-7; o) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-5WT-2; p) PROBP MOBILE STAND CORD ASSY UK, Product Code PWCD-5WT-4; q) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-5WT-6; r) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-5WT-7; s) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-6WT-2; t) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-6WT-6; u) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-6WT-7
Why the product was recalled
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Distribution information
Global, US: NY, IL
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.