Recall Z-1236-2007 ยท NGT Saline, Vascular Access Flush
B. Braun Medical, Inc.
Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.
| Date | Sep 20, 2007 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | Particulate matter in product. |
| Root cause | Other |
| Action | The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem. |
| Quantity | 1,292,520 units |
| Distribution | The products were shipped to distributors nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002142 | SALINE IV FLUSH SYRINGE Emt-Rx, Jan 28, 2002 |