MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk
Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to 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, specifically blood loss or air emboli, which aligns with the criteria for a Severe rating.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 1,575 units of the MedComp Repair Kit (REF RPK-01, UDI 884908039856). The recall is classified as Class II by the U.S. Food and Drug Administration. The product 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.
The recall was initiated because there is 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 lots include MCCC310, MCCA800, MCFH990, MCFC040, MCFA160, MKAB730, MCFW690, MCFS390, MCCC320, MCCL340, MCDD250, MCDD640, MCDP460, MCDDZSO, MCDVOSO, MCDV820, MCFN890, and MCFS930.
The product was 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 of these medical devices should contact the manufacturer for further instructions on how to handle the affected kits.
The recalled product
- Product
- REPAIR KIT, REF RPK-01, UDI 884908039856 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
- Affected units
- 1,575
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 (18)
- Lot Numbers: MCCC310
- MCCA800
- MCFH990
- MCFC040
- MCFA160
- MKAB730
- MCFW690
- MCFS390
- MCCC310
- MCCC320
- MCCL340
- MCDD250
- MCDD640
- MCDP460
- MCDDZSO
- MCDVOSO
- MCDV820
- MCFN890 & MCFS930.
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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