Recall Z-1311-04 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Merit Medical Systems, Inc
Merit MAK Mini Access Kit, 4 French (1.3mm)
| Date | Aug 4, 2004 (initiated Jul 20, 2004) |
| Status | Terminated |
| Reason | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. |
| Root cause | Other |
| Action | Consignees were notified by phone and letter on 7/20/2004. |
| Quantity | 634 kits |
| Distribution | Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031691 | MERIT MAK (MINI ACCESS KIT) Merit Medical Systems, Inc., Sep 3, 2003 |