[Recalled] 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there i
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 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. |
|---|---|
| Brand / manufacturer | Medical Components, Inc dba MedComp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1120-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 February 2018 |
| EAN / barcode | 884908005530 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Medical Components, Inc dba MedComp
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.