Recall Z-2537-2010 ยท FMI Needle, Hypodermic, Single Lumen
Multi-Med, Inc.
All Med Medical 19ga x 1.50" RA Hub Needle Model #M1915H Reorder #55-1940 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
| Date | Sep 29, 2010 (initiated Aug 30, 2010) |
| Status | Terminated |
| Reason | Huber needles may core and result in port leakage or emboli being flushed our of the port. |
| Root cause | Device Design |
| Action | Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733. |
| Quantity | 480 units |
| Distribution | Worldwide Distribution -- USA and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891919 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc., May 5, 1989 |