Product Description
Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
Reason for Recall
These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
Action Details
The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.
Distribution Pattern
Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
Code Information / Serial Numbers
Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.