Recalls / —

—#29052

Product

Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579

FDA product code

74DWF

510(k) numbers

K925442

Affected lot / code info

Lots 1203930 and 1203940.

Why it was recalled

Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

Root cause (FDA determination)

Other

Action the firm took

Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo.

Recalling firm

Firm

Terumo Cardiovascular Systems Corp

Address

6200 Jackson Rd., Ann Arbor, Michigan 48103

Distribution

Distribution pattern

United States, Canada, Chile, China, Germany and Japan.

Timeline

Recall initiated

2003-08-08

Posted by FDA

2003-08-29

Terminated

2004-03-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.