Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PhaSeal Intravascular Administration Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall PhaSeal Intravascular Administration Set see related information
Date Initiated by Firm June 26, 2007
Date Posted August 22, 2007
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-1180-2007
Recall Event ID 38251
510(K)Number K001368  
Product Classification Intravascular Administration Set - Product Code FPA
Product PhaSeal, Protector 21, Item No. 21, US Order No. 22020
Code Information P21 Cat. No. 22020
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
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.
-
-