B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
FDA device recall Z-0783-2007 · posted 2007-05-05 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- The integrity of the sterile product barrier may be compromised
- Action taken
- An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 180 units
- Distribution
- Nationwide distribution --- including states of GA, MA, OH, and TX
- Date initiated
- 2007-04-11
- Date posted
- 2007-05-05
- Date terminated
- 2007-08-07
- 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 |
|---|---|---|
| TPN FLUID TRANSFER SET (K905201) | Mcgaw, Inc. | 1991-01-02 |