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FDA Medical Device Recalls (openFDA)

Multi-Med, Inc.: All Med Medical 20ga x .75" Winged Administration Set w/Y Site Model # M2075Y Reorder # 50-2022

Recall number
Z-2516-2010
Recalling firm
Multi-Med, Inc.
Product
All Med Medical 20ga x .75" Winged Administration Set w/Y Site Model # M2075Y Reorder # 50-2022
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
45,537 units
Distribution
Worldwide Distribution -- USA and Mexico.
Lot, serial or model codes
Lot codes: 5J012A 6A003A 6B056A 6E004A 6E011A 6H052A 6K026A 6L005A 7A016A 7B060A 7C027A 7D001A 7F008A 7I010A 7L026A 8J065A 9E024A 9F020A 9G033A 9H018A
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

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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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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