Date Initiated by Firm |
April 11, 2007 |
Date Posted |
May 05, 2007 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0783-2007 |
Recall Event ID |
37855 |
510(K)Number |
K905201
|
Product Classification |
HyperFormer Pump Dispensing Set, - Product Code LHI
|
Product |
B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets. |
Code Information |
Lot number 0060911602 |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Boulevard Allentown PA 18109-9512
|
For Additional Information Contact |
Kimberly Paris 610-266-0500
|
Manufacturer Reason for Recall |
The integrity of the sterile product barrier may be compromised
|
FDA Determined Cause 2 |
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 in Commerce |
180 units |
Distribution |
Nationwide distribution --- including states of GA, MA, OH, and TX |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LHI and Original Applicant = MCGAW, INC.
|