The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
FDA Recall Z-0157-2007 · Posted 2006-11-07
Recalling FirmSt. Jude Medical / Daig Division
Recall StatusTerminated
Product CodeMGB
Date Initiated2006-06-07
Date Terminated2006-11-13
Product Quantity4,770 Units
Reason for Recall
The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
Firm Action
All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.