Multi-Med, Inc.: All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241

Recall number

Z-2531-2010

Recalling firm

Multi-Med, Inc.

Product

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

Status

Terminated

Initiated

2010-08-30

Posted

2010-09-29

Terminated

2013-01-31

Reason

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

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

41,893 units

Distribution

Worldwide Distribution -- USA and Mexico.

Lot, serial or model codes

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

510(k) numbers

["K891919"]

PMA numbers

not on file

Product code

FMI

Firm FEI

1221765

Firm city

Keene

Firm state

NH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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