Recall Z-0546-05 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
IV Flush LLC
Sodium Chloride Injection USP, manufactured by IV Flush LLC
| Date | Mar 1, 2005 (initiated Jan 26, 2005) |
| Status | Terminated |
| 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. |
| Distribution | Product was distributed nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.