Recall Z-0511-2019 ยท DQO Catheter, Intravascular, Diagnostic
Numed Inc
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
| Date | Oct 17, 2018 |
| Status | Terminated |
| Reason | Instructions for Use booklets were not included on the outer pouch |
| Root cause | Labeling design |
| Action | NuMED issued recall notification letter and response form on 10/17/2018 via email to the one distributor and followed up by a hard copy of the letter and response form sent via UPS Next Day Air. The letter identified the affected product, problem and actions to be taken. The customer was instructed to return affected product.. |
| Quantity | 100 units |
| Distribution | US distribution in the state of PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952984 | MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) Map Medical Equipment, Inc., Jan 29, 1996 |