Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number
FDA device recall Z-2411-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- incorrect burette was packaged with the product
- Action taken
- The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2340 units
- Distribution
- Nationwide.
- Date initiated
- 2008-06-30
- Date posted
- 2008-09-23
- Date terminated
- 2009-05-05
- 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 |
|---|---|---|
| V2 INJECTION SITE (K955585) | B.Braun Medical, Inc. | 1996-05-15 |
| MODIFICATION TO IV SPIKE (K921860) | Mcgaw, Inc. | 1992-07-30 |
| IV SET WITH GRADUATED CHAMBER (K781744) | National Patent Development Corp. | 1978-12-07 |