Vaccines, Blood & Biologics

Urgent Medical Device Recall: Stryker and Gamyar Blood/Fluid Warmer Cassettes

DATE RECALL INITIATED:  July 15, 2014

PRODUCT DESCRIPTION:

Brand Name: Medi-Temp Blood/Fluid Warming Cassette
Common Name: Blood/Fluid Warmer Sets

MODEL NUMBERS:

D25310NL, D25310CE, D25315CE, D25340CE

MANUFACTURER: 

Medisearch, Inc.
Guayama, PR

REASON:

Stryker Medical is voluntarily recalling Stryker and Gaymar brand Blood/Fluid Warmer Cassettes. Stryker Medical has received customer complaints in regards to malformed threads on the female luer fitting of specific models of blood/fluid warmer cassettes. Their investigation has found that malformed threads are caused during the bonding operation between the luer fitting and the tubing. Consignees are asked to locate and quarantine the affected lots and to contact Stryker to arrange for affected lots to be returned.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 08/05/2014
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