Recall Z-0519-2010 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.
| 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 | 5 Sheath Introducers |
| 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
| K050962 | MERIT PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc., May 6, 2005 |