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U.S. Department of Health and Human Services

Class 2 Device Recall PhaSeal Intravascular Administration Set

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 Class 2 Device Recall PhaSeal Intravascular Administration Setsee related information
Date Initiated by FirmJune 26, 2007
Date PostedAugust 22, 2007
Recall Status1 Terminated 3 on March 05, 2013
Recall NumberZ-1178-2007
Recall Event ID 38251
510(K)NumberK001368 
Product Classification Intravascular Administration Set - Product Code FPA
ProductPhaSeal, Protector 14, Item No. P14, US Order No. 21320
Code Information P14 Cat. No. 21320
FEI Number 3002897967
Recalling Firm/
Manufacturer		 Carmel Pharma, Inc.
7029 Huntley Road
Suite O
Columbus OH 43229
For Additional Information ContactJoanne 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
ActionOn 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 Commerce6.1 million for Z-1178-1181-2007 recalls
DistributionProduct was distributed throughout the US and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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