Z-0219-06

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part...

Name: Z-0219-06 Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part...
Creator: LeMaitre Vascular, Inc.
Published: 2005-05-17
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2005-05-17 / Terminated / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre... on 2005-05-17. The reason FDA records is "LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0219-06
Status: Terminated
Initiated: 2005-05-17
Posted: 2005-11-30
Terminated: 2012-07-06
Recalling firm: LeMaitre Vascular Inc.
Product: 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***''.
Product code: DQT Occluder, Catheter Tip
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 1,919
Distribution: 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.
Product codes and lots: Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.

Product code DQT

K872090Class IIThe Robicsek - Pruitt Aortic Balloon Occlusion KitIdeas For Medicine, Inc. / cleared 1987-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)