Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul
FDA device recall Z-1439-04 · posted 2004-09-09 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- drug ampuls in kits contain particulates
- Action taken
- The recalling firm/kit manufacturer issued a recall letter dated 7/8/04 to its customers informing them of the problem and to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSP
- Quantity affected
- 2261 cases
- Distribution
- The products were shipped to 145 medical facilities and 79 distributors nationwide. The products were also shipped to 6 government accounts in FL, NC, NY, OH, and PA.
- Date initiated
- 2004-07-06
- Date posted
- 2004-09-09
- Date terminated
- 2004-11-30
- 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 |
|---|---|---|
| SPINOCAN SPINAL NEEDLE (K820047) | Burron Medical Products, Inc. | 1982-01-25 |