MedComp recalls 12F Tesio Catheter Sets with specific lot numbers due to potential connection failures that could cause blood loss or air emboli. Affected units include MCTC1235SD model with UDI 884908027242.
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
MedComp is recalling 12F Tesio Catheter Sets (model MCTC1235SD) with specific lot numbers because faulty connections might cause blood loss or air emboli. This is a serious risk for patients using hemodialysis equipment.
The catheter set has a female two-part luer connector that can fail when connecting to hemodialysis blood tubing lines. This failure may lead to blood loss or air emboli, which are serious medical complications.
Patients using hemodialysis treatments with this catheter set are most at risk. Healthcare providers who use the product for medical procedures may also be affected.
Check for the model number MCTC1235SD and lot numbers listed: MCBP460, MCFJ310, MCDP870, MCFY580, MCFT400, MKAFOSO, MCDF810, MCDGllO, MCDG210, MCCW260, MCFJ310, and MCFQ070. The unique device identifier (UDI) is 884908027242.
Identify the model number MCTC1235SD and lot numbers listed in the recall notice to confirm if your catheter set is affected.
Reach out to MedComp directly for assistance with the repair kit or replacement options.
The model number is MCTC1235SD.
Affected lot numbers include MCBP460, MCFJ310, MCDP870, MCFY580, MCFT400, MKAFOSO, MCDF810, MCDGllO, MCDG210, MCCW260, MCFJ310, and MCFQ070.
Yes, the Medcomp Repair Kit is provided for replacing damaged female connectors, clamps, or repairing extensions with at least 4.5cm of viable tubing.
We’ve drafted a message you can send MedComp to request your refund or repair — edit it as you like.
Subject: Recall Z-1122-2018 — MedComp MedComp Hello, I own a MedComp that is covered by recall Z-1122-2018 from MedComp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
