Recall Z-0357-2007 ยท GCJ Laparoscope, General & Plastic Surgery
Continental Medical Labs,Inc
Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central. Manufactured in t
| Date | Jan 18, 2007 (initiated Oct 18, 2006) |
| Status | Terminated |
| Reason | Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper. |
| Root cause | Process control |
| Action | Consignee was notified by certified mail on 10/19/06. |
| Quantity | 840 kits |
| Distribution | Product was distributed to one consignee located in Wisconsin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.