FDA Medical Device Recalls (openFDA)
Multi-Med, Inc.: All Med Medical 20ga x 1.5" Straight Hub Needle Model #M2015HS Reorder #55-2045 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
- Recall number
- Z-2543-2010
- Recalling firm
- Multi-Med, Inc.
- Product
- All Med Medical 20ga x 1.5" Straight Hub Needle Model #M2015HS Reorder #55-2045 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
- 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
- 20,335 units
- Distribution
- Worldwide Distribution -- USA and Mexico.
- Lot, serial or model codes
- Lot codes: 6A061A 6E030A 6E056A 6J014A 6K035A 7D006A 7E047A 7H022A 8J030A 8K005A 9B014A 9B044A 9H003A
- 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