Multi-Med, Inc.: All Med Medical 20ga x 1" Winged Administration Set w/Y Site Model # M201Y Reorder # 50-2032

Recall number

Z-2519-2010

Recalling firm

Multi-Med, Inc.

Product

All Med Medical 20ga x 1" Winged Administration Set w/Y Site Model # M201Y Reorder # 50-2032

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

31,261 units

Distribution

Worldwide Distribution -- USA and Mexico.

Lot, serial or model codes

Lot code: 5G055A 5J034A 5J036A 6H027A 6I010A 6J053A 6K027A 7J008A 8D025A 8F029A 8L043A 9A024A

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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