MedComp Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that 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 rubric criteria for 'Severe' (score 4) involving significant injury reports or high-risk structural defects.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 5 units of the MedComp Repair Kit (Reference ARA101, UDI 884908083637). 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 is being issued 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 units, identified by Lot Number MCFH090, were distributed worldwide. In the United States, distribution occurred in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI. International distribution included Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain, Greece, Ireland, Israel, Italy, Netherlands, South Africa, Spain, Sweden, Turkey, and the United Arab Emirates.
The recalled product
- Product
- REPAIR KIT, REF ARA101, UDI 884908083637 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
- 5
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 (1)
- Lot Number: MCFH090
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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