Z-2531-2010

All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241

Name: Z-2531-2010 All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241
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 All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241 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-2531-2010
Status: Terminated
Initiated: 2010-08-30
Posted: 2010-09-29
Terminated: 2013-01-31
Recalling firm: Multi-Med, Inc.
Product: All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241
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: 41,893 units
Distribution: Worldwide Distribution -- USA and Mexico.
Product codes and lots: Lot code: 6A030A 6F031A 6H050A 6L044A 7A040A 7D048A 7G012A 7J055A 7K035A 7L019A 7L024A 8H044A 8I014A 8I044A 8L022A 8L033A 9B034A 9C034A 9D021A 9F037A 9F049A 9J032A 9K029A

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)