Recall Z-0937-2013 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Vygon Corporation
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
| Date | Mar 11, 2013 (initiated Dec 17, 2012) |
| Status | Terminated |
| Reason | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. |
| Root cause | Component change control |
| Action | Churchill Medical Systems sent a letter to their consignees on December 19, 2012. |
| Quantity | 210 |
| Distribution | Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081904 | PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) Medcomp, Sep 23, 2008 |