Date Initiated by Firm |
April 18, 2007 |
Date Posted |
May 31, 2007 |
Recall Status1 |
Terminated 3 on April 22, 2008 |
Recall Number |
Z-0819-2007 |
Recall Event ID |
37856 |
510(K)Number |
K955585 K904518
|
Product Classification |
IV Set - Product Code FPA
|
Product |
Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. |
Code Information |
Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11 |
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 |
Secondary infusion backs up into primary container.
|
FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
2.5 million for all products |
Distribution |
Nationwide and Canada. |
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 = FPA and Original Applicant = B. BRAUN MEDICAL, INC. 510(K)s with Product Code = FPA and Original Applicant = KENDALL MCGAW LABORATORIES, INC.
|