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Terminated

Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356

FDA Recall Z-1484-05 · Posted 2005-09-02

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKOB
Date Initiated2005-07-22
Date Terminated2007-06-20

Reason for Recall

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Firm Action

Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Root Cause

Other

Distribution Pattern

Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula

Official Source

View FDA Recall →

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

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