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U.S. Department of Health and Human Services

Class 3 Device Recall Prowler Plus

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  Class 3 Device Recall Prowler Plus see related information
Date Initiated by Firm October 19, 2001
Date Posted October 15, 2003
Recall Status1 Terminated 3 on May 11, 2004
Recall Number Z-0018-04
Recall Event ID 26334
510(K)Number K003925  
Product 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.
Code Information Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05
Recalling Firm/
Manufacturer
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes FL 33014
For Additional Information Contact Jacqueline Maestri
800-898-9481
Manufacturer 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.
FDA Determined
Cause 2
Other
Action 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.
Quantity in Commerce 54
Distribution Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = and Original Applicant = CORDIS NEUROVASCULAR, INC.
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