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Welch Allyn Connex Integrated Wall System, Product… recallZ-1562-2025 · Baxter Healthcare Corporation · initiated Mar 21, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDA root cause category: Device Design

What the company is doing

Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/21/2025 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate the impacted products (see Attachment A for details) at your facility that are unopened. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed Reply Form Instruction Sheet, even if you have no remaining inventory. 3. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for the return and exchange of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Director of Nursing, and any other departments within your institution who unpack the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) and you have an affected product please do not distribute. Contact Baxter Technical Support for additional instructions. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, please contact Baxter Technical Support between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday at 800-535-6663. Press option 2, then select option 1 or 2 for language preference, then press option 2.

Recall details

Recall number
Z-1562-2025
Status
Open, Classified
Initiated by the company
Mar 21, 2025
Posted by the FDA
Apr 15, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
8233 units
Product code
DXQ
FDA submissions
K171621
Distribution
Worldwide distribution.

Product description

Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B; 18) 84MTVXX-2; 19) 84MXVEC-4; 20) 84MXVEC-B; 21) 84MXVEP-4; 22) 84MXVEP-B; 23) 84NTVE2-6; 24) 84NTVE2-B; 25) 84NTVE2-US; 26) 84NTVEC-B; 27) 84NTVX2-6; 28) 84NTVX2-B; 29) 84NTVX2-US; 30) 84NTVXC-4; 31) 84NTVXC-B; 32) 84NTVXP-B; 33) 84NXVEC-4; 34) 84NXVEC-6; 35) 84NXVEC-B; 36) 84XTVXC-2; 37) 84XTVXC-B; 38) 85MTVE3-2; 39) 85MTVE3-4; 40) 85MTVE3-B; 41) 85MTVE3-US; 42) 85MTVEC-4; 43) 85MTVEC-B; 44) 85MTVEP-2; 45) 85MTVEP-B; 46) 85MTVX3-4; 47) 85MTVX3-B; 48) 85MTVX3-US; 49) 85MTVXC-6; 50) 85MTVXC-B; 51) 85MTVXX-6; 52) 85MXVEC-2; 53) 85MXVEC-4; 54) 85MXVEC-B; 55) 85MXVEP-4; 56) 85NTVE3-4; 57) 85NTVE3-6; 58) 85NTVE3-B; 59) 85NTVE3-US; 60) 85NTVEC-B; 61) 85NTVEP-2; 62) 85NTVEP-6; 63) 85NTVEP-B; 64) 85NTVX3-6; 65) 85NTVX3-B; 66) 85NTVX3-US; 67) 85NTVXC-B; 68) 85NTVXP-2; 69) 85NTVXP-B; 70) 85NXVEC-4; 71) 85NXVEC-B; 72) 85NXVEP-6.

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

1) Product Code/Part # 84MTVE2-4, UDI/DI 00732094350548; 2) Product Code/Part # 84MTVE2-6, UDI/DI 00732094350463; 3) Product Code/Part # 84MTVE2-B, UDI/DI 00732094349856; 4) Product Code/Part # 84MTVE2-US, UDI/DI 00732094350388; 5) Product Code/Part # 84MTVEC-6, UDI/DI 00732094058741; 6) Product Code/Part # 84MTVEC-B, UDI/DI 00732094058734; 7) Product Code/Part # 84MTVEP-B, UDI/DI 00732094119442; 8) Product Code/Part # 84MTVEX-4, UDI/DI 00732094198638; 9) Product Code/Part # 84MTVX2-4, UDI/DI 00732094350531; 10) Product Code/Part # 84MTVX2-6, UDI/DI 00732094350456; 11) Product Code/Part # 84MTVX2-B, UDI/DI 00732094349849; 12) Product Code/Part # 84MTVX2-US, UDI/DI 00732094350371; 13) Product Code/Part # 84MTVXC-4, UDI/DI 00732094058550; 14) Product Code/Part # 84MTVXC-B, UDI/DI 00732094058512; 15) Product Code/Part # 84MTVXP-2, UDI/DI 00732094198607; 16) Product Code/Part # 84MTVXP-4, UDI/DI 00732094058390; 17) Product Code/Part # 84MTVXP-B, UDI/DI 00732094058352; 18) Product Code/Part # 84MTVXX-2, UDI/DI 00732094198584; 19) Product Code/Part # 84MXVEC-4, UDI/DI 00732094198553; 20) Product Code/Part # 84MXVEC-B, UDI/DI 00732094058277; 21) Product Code/Part # 84MXVEP-4, UDI/DI 00732094058260; 22) Product Code/Part # 84MXVEP-B, UDI/DI 00732094058222; 23) Product Code/Part # 84NTVE2-6, UDI/DI 00732094350449; 24) Product Code/Part # 84NTVE2-B, UDI/DI 00732094349832; 25) Product Code/Part # 84NTVE2-US, UDI/DI 00732094350364; 26) Product Code/Part # 84NTVEC-B, UDI/DI 00732094058048; 27) Product Code/Part # 84NTVX2-6, UDI/DI 00732094350432; 28) Product Code/Part # 84NTVX2-B, UDI/DI 00732094349825; 29) Product Code/Part # 84NTVX2-US, UDI/DI 00732094350357; 30) Product Code/Part # 84NTVXC-4, UDI/DI 00732094198362; 31) Product Code/Part # 84NTVXC-B, UDI/DI 00732094057775; 32) Product Code/Part # 84NTVXP-B, UDI/DI 00732094057713; 33) Product Code/Part # 84NXVEC-4, UDI/DI 00732094057652; 34) Product Code/Part # 84NXVEC-6, UDI/DI 00732094057638; 35) Product Code/Part # 84NXVEC-B, UDI/DI 00732094057485; 36) Product Code/Part # 84XTVXC-2, UDI/DI 00732094198096; 37) Product Code/Part # 84XTVXC-B, UDI/DI 00732094057065; 38) Product Code/Part # 85MTVE3-2, UDI/DI 00732094350586; 39) Product Code/Part # 85MTVE3-4, UDI/DI 00732094350500; 40) Product Code/Part # 85MTVE3-B, UDI/DI 00732094349818; 41) Product Code/Part # 85MTVE3-US, UDI/DI 00732094350340; 42) Product Code/Part # 85MTVEC-4, UDI/DI 00732094197808; 43) Product Code/Part # 85MTVEC-B, UDI/DI 00732094118964; 44) Product Code/Part # 85MTVEP-2, UDI/DI 00732094056211; 45) Product Code/Part # 85MTVEP-B, UDI/DI 00732094056174; 46) Product Code/Part # 85MTVX3-4, UDI/DI 00732094350494; 47) Product Code/Part # 85MTVX3-B, UDI/DI 00732094349801; 48) Product Code/Part # 85MTVX3-US, UDI/DI 00732094350333; 49) Product Code/Part # 85MTVXC-6, UDI/DI 00732094196221; 50) Product Code/Part # 85MTVXC-B, UDI/DI 00732094056075; 51) Product Code/Part # 85MTVXX-6, UDI/DI 00732094196245; 52) Product Code/Part # 85MXVEC-2, UDI/DI 00732094197693; 53) Product Code/Part # 85MXVEC-4, UDI/DI 00732094197686; 54) Product Code/Part # 85MXVEC-B, UDI/DI 00732094118940; 55) Product Code/Part # 85MXVEP-4, UDI/DI 00732094055887; 56) Product Code/Part # 85NTVE3-4, UDI/DI 00732094350487; 57) Product Code/Part # 85NTVE3-6, UDI/DI 00732094350401; 58) Product Code/Part # 85NTVE3-B, UDI/DI 00732094349795; 59) Product Code/Part # 85NTVE3-US, UDI/DI 00732094350326; 60) Product Code/Part # 85NTVEC-B, UDI/DI 00732094055740; 61) Product Code/Part # 85NTVEP-2, UDI/DI 00732094197532; 62) Product Code/Part # 85NTVEP-6, UDI/DI 00732094196320; 63) Product Code/Part # 85NTVEP-B, UDI/DI 00732094055597; 64) Product Code/Part # 85NTVX3-6, UDI/DI 00732094350395; 65) Product Code/Part # 85NTVX3-B, UDI/DI 00732094349788; 66) Product Code/Part # 85NTVX3-US, UDI/DI 00732094350319; 67) Product Code/Part # 85NTVXC-B, UDI/DI 00732094055467; 68) Product Code/Part # 85NTVXP-2, UDI/DI 00732094055443; 69) Product Code/Part # 85NTVXP-B, UDI/DI 00732094055412; 70) Product Code/Part # 85NXVEC-4, UDI/DI 00732094055252; 71) Product Code/Part # 85NXVEC-B, UDI/DI 00732094055207; 72) Product Code/Part # 85NXVEP-6, UDI/DI 00732094196375; Lot Number 24-314 & lower

Devices named in this recall

24 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96364).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page