Recall Z-1122-2018— Medical Components, Inc dba MedComp
Class II · Terminated
Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2018-02-23, terminated 2020-01-10. It names one FDA 510(k) clearance: K022570. Product: 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 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.. Reason: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli..
- Recalling firm
- Medical Components, Inc dba MedComp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-23
- Terminated
- 2020-01-10
- Firm location
- Harleysville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 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.
Reason for recall
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Data sourced from openFDA. This site is unofficial and independent of the FDA.