Welch Allyn Connex Vital Signs Monitor Recall: Undeclared Natural Rubber
Baxter Healthcare Corporation is recalling certain Welch Allyn Connex Vital Signs Monitors due to an undeclared natural rubber band in the packaging of reusable blood pressure cuffs. The undeclared rubber may pose an allergen risk to individuals with natural rubber latex sensitivity.
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 recall involves allergen mislabeling (undeclared natural rubber latex) on a medical device with potential to harm a sensitized population. No illnesses are reported in the source, but the hazard is a known allergen, which falls under the High severity criterion for allergen mislabeling without reported illness.
Plain-English summary
Baxter Healthcare Corporation is recalling certain configurations of the Welch Allyn Connex Vital Signs Monitor (40,166 units worldwide) because the packaging of reusable blood pressure cuffs contains an undeclared natural rubber band.
The undeclared natural rubber may present an allergen risk to individuals with sensitivity or allergy to natural rubber latex. The defect affects multiple product codes and serial lot numbers 24-314 and lower.
Users of affected Welch Allyn Connex Vital Signs Monitors should contact Baxter Healthcare Corporation for instructions regarding the return or replacement of the affected blood pressure cuffs. Healthcare facilities and individuals who have received these devices should cease use of the reusable blood pressure cuffs until they receive replacement products without the undeclared natural rubber packaging component.
The recalled product
- Product
- Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 40,166
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)
- 1) Product Code/Part # 67MXTP-B-ECG3A
- UDI/DI 00732094323788
- 2) Product Code/Part # 67MXTX-B
- UDI/DI 00732094151244
- 3) Product Code/Part # 67MXXP-B
- UDI/DI 00732094151237
- 4) Product Code/Part # 67MXXX-B
- UDI/DI 00732094151220
- 5) Product Code/Part # 67NCTP-B
- UDI/DI 00732094151190
- 6) Product Code/Part # 67NCTP-B-ECG3A
- UDI/DI 00732094323771
- 7) Product Code/Part # 67NCTX-B
- UDI/DI 00732094151183
- 8) Product Code/Part # 67NXEX-B
- UDI/DI 00732094151145
- 9) Product Code/Part # 67NXTP-B
- UDI/DI 00732094151138
- 10) Product Code/Part # 67NXTP-B-ECG3A
- UDI/DI 00732094323764
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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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