Z-2563-2010

Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model #...

Name: Z-2563-2010 Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model #...
Creator: Multi-Med, Inc.
Published: 2010-08-30
License: https://open.fda.gov/license/

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

FDA source

Multi-Med, Inc. began a recall of Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model # MWS201 Intended to be used to inject fluids into... on 2010-08-30. The reason FDA records is "Huber needles may core and result in port leakage or emboli being flushed our of the port". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2563-2010
Status: Terminated
Initiated: 2010-08-30
Posted: 2010-09-29
Terminated: 2013-01-31
Recalling firm: Multi-Med, Inc.
Product: Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model # MWS201 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: 20,550
Distribution: Worldwide Distribution -- USA and Mexico.
Product codes and lots: Lot Code: 5l060M 6A060M 6B052M 6E028M 6H056M 6I039M 7B016M 7D008M 7E056M 7F038M 7F039M 7G052M 7K053M 8F055M 9E048M 0D003M

Product code FMI

K891919Class IIIntravascular Administration SetMulti-Med, Inc. / cleared 1989-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)