Recall Z-0783-2007 ยท LHI Set, I.V. Fluid Transfer
B. Braun Medical, Inc.
B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
| Date | May 5, 2007 (initiated Apr 11, 2007) |
| Status | Terminated |
| Reason | The integrity of the sterile product barrier may be compromised |
| Root cause | Other |
| Action | 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. |
| Quantity | 180 units |
| Distribution | Nationwide distribution --- including states of GA, MA, OH, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905201 | TPN FLUID TRANSFER SET Mcgaw, Inc., Jan 2, 1991 |