MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may 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 is classified as FDA Class II and involves a risk of significant injury (blood loss or air emboli), which meets the criteria for a Severe rating.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 12F Tesio Catheter Sets (Reference MCTC1247SD, UDI 884908027266). The recall involves specific lot numbers: MCBM830, MCDZ620, and MCDP130.
The recall is due to the 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 various international locations such as Australia, Canada, and several European and Middle Eastern countries. Users should contact the manufacturer for further instructions.
The recalled product
- Product
- 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 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
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.
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