Vaxcel Chest Ports - Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-303
FDA Recall Z-1475-05 · 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.