All Med Medical 19ga x .50" RA Hub Needle Model #M195H Reorder #55-1910 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
Recall
- Recall Number
- Z-2534-2010
- Event Number
- 56548
- Firm
- Multi-Med, Inc.
- FEI Number
- 1221765
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 30, 2010
- Posted
- September 29, 2010
- Terminated
- January 31, 2013
- Address
- 26 Victoria Court, Keene, NH, 03431
Description
All Med Medical 19ga x .50" RA Hub Needle Model #M195H Reorder #55-1910 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
Huber needles may core and result in port leakage or emboli being flushed our of the port.
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.
Worldwide Distribution -- USA and Mexico.
144 units