Recalls / —

—#28146

Product

9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath

510(k) numbers

K940079

Affected lot / code info

Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.

Why it was recalled

separation of sheath

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605

Distribution

Distribution pattern

The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.

Timeline

Recall initiated

2003-07-08

Posted by FDA

2003-07-19

Terminated

2004-09-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.