Sodium Chloride Injection USP, manufactured by IV Flush LLC
FDA device recall Z-0546-05 · posted 2005-03-01 · Terminated
Recall details
- Recalling firm
- IV Flush LLC
- Reason for recall
- Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Distribution
- Product was distributed nationwide.
- Date initiated
- 2005-01-26
- Date posted
- 2005-03-01
- Date terminated
- 2008-09-17
- Location
- Rowlett, TX
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