Date Initiated by Firm |
June 26, 2007 |
Date Posted |
August 22, 2007 |
Recall Status1 |
Terminated 3 on March 05, 2013 |
Recall Number |
Z-1181-2007 |
Recall Event ID |
38251 |
510(K)Number |
K001368
|
Product Classification |
Intravascular Administration Set - Product Code FPA
|
Product |
PhaSeal, Protector 50, Item No. 50, US Order No. 10310 |
Code Information |
P50 Cat. No. 22050 |
Recalling Firm/ Manufacturer |
Carmel Pharma, Inc. 7029 Huntley Road Suite O Columbus OH 43229
|
For Additional Information Contact |
Joanne Beyer 614-487-9250
|
Manufacturer Reason for Recall |
Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
|
FDA Determined Cause 2 |
Other |
Action |
On or about 6/15/2007, the firm sent advisory notice letters to the end users and the instructions for use have been updated by adding a precaution statement regarding the use of thick rubber stoppers. The firm is also updating the customer training program to include how to handle drug vials with thick concave rubber stoppers. |
Quantity in Commerce |
6.1 million for Z-1178-1181-2007 recalls |
Distribution |
Product was distributed throughout the US and Canada |
Total Product Life Cycle |
TPLC Device Report
|
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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 = CARMEL PHARMA AB.
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