FDA Recall Terminated

Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set Model # MW191-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

Recall: Z-2551-2010 · Initiated August 30, 2010

Recall

Recall Number
Z-2551-2010
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

Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set Model # MW191-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

Reason

Huber needles may core and result in port leakage or emboli being flushed our of the port.

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.

Distribution

Worldwide Distribution -- USA and Mexico.

Quantity

1,225 units