Recall Z-0514-2010 ยท DXT Injector And Syringe, Angiographic
Merit Medical Systems, Inc.
Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices.
| Date | Dec 14, 2009 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | Potential sterility breach caused by excessive shipment damage. |
| Root cause | Other |
| Action | Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
| Quantity | 25 angiographic needles |
| Distribution | US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.