FDA Device recall Z-1122-2018
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in… by Medical Components, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1122-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medical Components |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: MCBP460, MCFJ310, MCDP870, MCFY580, MCFT400, MKAFOSO, MCDF810, MCDGllO, MCDG210, MCCW260, MCFJ310 & MCFQ070. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1122-2018%22
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