FDA Medical Device Recalls (openFDA)
Multi-Med, Inc.: All Med Medical 20ga x 1" Winged Administration Set Model # M201 Reorder # 50-2031
- Recall number
- Z-2518-2010
- Recalling firm
- Multi-Med, Inc.
- Product
- All Med Medical 20ga x 1" Winged Administration Set Model # M201 Reorder # 50-2031
- 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
- 22,808 units
- Distribution
- Worldwide Distribution -- USA and Mexico.
- Lot, serial or model codes
- Lot code: 5G059A 5H042A 5K013A 5K022A 6K034A 7A002A 7I036A 7J007A 9F036A 9F044A
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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