Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets.
FDA device recall Z-0818-2007 · posted 2007-05-31 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Secondary infusion backs up into primary container.
- Action taken
- The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2.5 million for all products
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-04-18
- Date posted
- 2007-05-31
- Date terminated
- 2008-04-22
- 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 |
| VOLUMETRIC INFUSION PUMP (K904518) | Kendall Mcgaw Laboratories, Inc. | 1990-10-17 |