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Terminated

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

FDA Recall Z-1035-03 · Posted 2003-07-19

Recalling FirmArrow International Inc
Recall StatusTerminated
Date Initiated2003-07-08
Date Terminated2004-09-02
Product Quantity13442 units

Reason for Recall

separation of sheath

Firm Action

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.

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903Arrow Intl., Inc. · 1994-11-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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