MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures
Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a potential for serious injury (blood loss or air emboli), which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 40 kits of 12F Modified Tesio Catheter Sets (Reference MCTC1235SM, UDI 884908027259). The affected lots are MCBM830, MCDZ620, and MCDP130. The product is indicated for use in replacing damaged female luer connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
The recall was initiated because there is a potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines. These failures may contribute to blood loss or air emboli.
The affected products were distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Canada, France, Germany, and the United Kingdom. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheter
- Affected units
- 40
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 (2)
- Lot Numbers: MCBM830
- MCDZ620 & MCDP130.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Medical Components, Inc dba MedComp 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.
See all 10 products in this recall →Related recalls
Same manufacturer · Medical Components, Inc dba MedComp
See all →- ModerateMedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size
FDA (Devices) · 2021-03-17
- ModerateMedcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size
FDA (Devices) · 2020-09-16
- SevereMedComp C3 Wave App Recalled Due to ECG Display Failure
FDA (Devices) · 2019-11-06
- ModerateMedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch
FDA (Devices) · 2019-08-14
- ModerateMedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error
FDA (Devices) · 2019-08-14
Same hazard · blood loss
See all →- HighPeripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk
FDA (Devices) · 2026-08-05
- HighMidline Catheter Recalled Over Risk of Leaking or Cracking at Hub
FDA (Devices) · 2026-08-05
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- SevereMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08