MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 55 Tesio Catheter Sets because potential connection failures could lead to blood loss or air emboli.
What this means for you
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: The recall involves a medical device with a risk of serious harm (blood loss or air emboli) but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 55 units of the 12F x 60cm Tesio Catheter Set with "Y" Adaptor (Ref CMD757, UDI 884908005554). The recall involves specific lot numbers: MCCD870, MCDK730, MCDN640, MCCS670, MCDR570, and MCDS970.
The recall was initiated 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 countries.
Healthcare providers and consumers should stop using the affected catheter sets immediately. Users should contact Medical Components, Inc. for further instructions on how to return or replace the devices.
The recalled product
- Product
- 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 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
- 55
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 (3)
- Lot Numbers: MCCD870 I MCDK730 I MCDN640
- MCCS670
- MCDR570 & MCDS970.
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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