Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2574-2010

Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Huber Trap Model # MW223-HT Intended to be...

Multi-Med, Inc. / initiated 2010-08-30 / Terminated / root cause: design

Multi-Med, Inc. began a recall of Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Huber Trap Model # MW223-HT Intended to be used to inject fluids into, withdraw fluids from... on . The reason FDA records is "Huber needles may core and result in port leakage or emboli being flushed our of the port". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2574-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Multi-Med, Inc.
Product
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Huber Trap Model # MW223-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
Product code
FMI Needle, Hypodermic, Single Lumen
Reason for recall
Huber needles may core and result in port leakage or emboli being flushed our of the port.
Root cause tag
design
FDA 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 in commerce
2,804 units
Distribution
Worldwide Distribution -- USA and Mexico.
Product codes and lots
Lot Code:   5H049M   5I007M   5I061M   8J034M   9E034M