Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.

FDA Recall Z-1482-06 · Posted 2006-09-02

Recalling FirmCordis Neurovascular, Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2006-08-11
Date Terminated2008-11-25
Product Quantity15 Lot numbers (46,452)

Reason for Recall

Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.

Firm Action

All consignees were notified by letter on 8/14/06. All Cordis Neurovascular sales representatives will also participate, to ensure expedited communication.

Root Cause

Other

Distribution Pattern

Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021591PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPSCordis Neurovascular, Inc. · 2002-05-22

Official Source

View FDA Recall →

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

↑