FDA Medical Device Recalls (openFDA)
IV Flush LLC: Sodium Chloride Injection USP, manufactured by IV Flush LLC
- Recall number
- Z-0546-05
- Recalling firm
- IV Flush LLC
- Product
- Sodium Chloride Injection USP, manufactured by IV Flush LLC
- Status
- Terminated
- Initiated
- 2005-01-26
- Posted
- 2005-03-01
- Terminated
- 2008-09-17
- Reason
- Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
- Root cause
- Other
- Action
- The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.
- Quantity
- not on file
- Distribution
- Product was distributed nationwide.
- Lot, serial or model codes
- All lots remaining on the market.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3004978897
- Firm city
- Rowlett
- Firm state
- TX
- 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