Z-1181-2007

PhaSeal, Protector 50, Item No. 50, US Order No. 10310

Name: Z-1181-2007 PhaSeal, Protector 50, Item No. 50, US Order No. 10310
Creator: Carmel Pharma, Inc.
Published: 2007-06-26
License: https://open.fda.gov/license/

Carmel Pharma AB. / initiated 2007-06-26 / Terminated

FDA source

Carmel Pharma, Inc. began a recall of PhaSeal, Protector 50, Item No. 50, US Order No. 10310 on 2007-06-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1181-2007
Status: Terminated
Initiated: 2007-06-26
Posted: 2007-08-22
Terminated: 2013-03-05
Recalling firm: Carmel Pharma AB.
Product: PhaSeal, Protector 50, Item No. 50, US Order No. 10310
Product code: FPA Set, Administration, Intravascular
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 root cause: 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
Product codes and lots: P50 Cat. No. 22050

Product code FPA

K001368Class IIProtector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterCarmel Pharma Ab. / cleared 2000-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)