Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
FDA Recall Z-0219-06 · Posted 2005-11-30
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDQT
Date Initiated2005-05-17
Date Terminated2012-07-06
Product Quantity1,919
Reason for Recall
LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
Firm Action
The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.
Root Cause
Other
Distribution Pattern
There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
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.
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