—#34325

Product

Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed balloon, standard length, 12'' (30.5 cm) long; catalog number 5586.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: All lots.

Why it was recalled

The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.

Root cause (FDA determination)

Other

Action the firm took

The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.

Timeline

Recall initiated: 2004-07-07
Posted by FDA: 2004-08-17
Terminated: 2004-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34325. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.