PhaSeal, Protector 50, Item No. 50, US Order No. 10310
FDA Recall Z-1181-2007 · Posted 2007-08-22
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Recalling FirmCarmel Pharma, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2007-06-26
Date Terminated2013-03-05
Product Quantity6.1 million for Z-1178-1181-2007 recalls
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed throughout the US and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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