Recall Z-0898-2013 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Medical Components, Inc dba MedComp
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
| Date | Feb 28, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | The affected 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 | Nonconforming Material/Component |
| Action | Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201 |
| Quantity | 785 |
| Distribution | USA Nationwide Distribution including the state of PA. |
| 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 |