Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton
FDA device recall Z-1235-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Particulate matter in product.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 33,240 units
- Distribution
- The products were shipped to distributors nationwide.
- Date initiated
- 2007-07-30
- Date posted
- 2007-09-20
- Date terminated
- 2008-04-01
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALINE IV FLUSH SYRINGE (K002142) | Emt-Rx | 2002-01-28 |