Medical Device Recall: Blood Pressure Monitors With Defective Power Cord Insulation
Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.
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 3/5 (High).
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: This is an FDA Class II recall of medical devices with power cord insulation defects that do not meet country-specific and international electrical safety standards. The hazard represents a risk-of-harm situation without reported injuries or illnesses, which qualifies as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling approximately 11,154 units of Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Devices. The affected models are distributed globally, including in the United States, Europe, UK, Australia, and South Africa.
The recall was initiated because the power cord construction does not meet the insulation rating required by country-specific electrical safety requirements and international standards. Baxter received reports identifying this compliance issue.
These blood pressure monitors are medical devices used to measure blood pressure in clinical and healthcare settings. The defective insulation on the power cord poses a potential electrical safety risk.
No injuries or illnesses related to this issue have been reported. Individuals or healthcare facilities with the affected devices should contact Baxter Healthcare Corporation for information about remedy options.
The recalled product
- Product
- 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…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 11,154
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 (20)
- a) 34BFST-2
- UDI/DI 732094009385
- b) 34BFST-4
- UDI/DI 732094009378
- c) 34BFST-6
- UDI/DI 732094009361
- d) 34BXST-2
- UDI/DI 732094009248
- e) 34BXST-4
- UDI/DI 732094167733
- f) 34BXST-7
- UDI/DI 732094009231
- g) 34XFST-2
- UDI/DI 732094009057
- h) 34XFST-4
- UDI/DI 732094009040
- i) 34XFST-6
- UDI/DI 732094009033
- j) 34XFST-7
- UDI/DI 732094009026
Distribution
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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