Carmel Pharma, Inc. PhaSeal, Protector 50, Item No. 50, US Order No. 10310 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PhaSeal, Protector 50, Item No. 50, US Order No. 10310
Brand
Carmel Pharma, Inc.
Lot Codes / Batch Numbers
P50 Cat. No. 22050
Products Sold
P50 Cat. No. 22050
Carmel Pharma, Inc. is recalling PhaSeal, Protector 50, Item No. 50, US Order No. 10310 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026