MedComp Catheter Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 315 Catheter Repair Kits due to potential connection failures that could cause 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 315 units of the Catheter Repair Kit, Reference RMS52001. The recall is due to the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines.
These connection 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.
Healthcare providers and patients should stop using the affected kits immediately. The specific lot numbers involved are MCBX400, MCFA150, MCFT460, MCCHOlO, MCDN490, MCCV190, MCCZ680, MCDDlOO, MCDV170, and MCDW310.
The recalled product
- Product
- CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 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 — Hemodialysis
- Affected units
- 315
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 (10)
- Lot Numbers: MCBX400
- MCFA150
- MCFT460
- MCCHOlO
- MCDN490
- MCCV190
- MCCZ680
- MCDDlOO
- MCDV170
- MCDW310
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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