Z-0018-04

Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD...

Name: Z-0018-04 Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD...
Creator: Cordis Neurovascular, Inc.
Published: 2001-10-19
License: https://open.fda.gov/license/

Cordis Neurovascular, Inc. / initiated 2001-10-19 / Terminated / root cause: labeling and UDI

FDA source

Cordis Neurovascular, Inc. began a recall of 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... on 2001-10-19. The reason FDA records is "These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0018-04
Status: Terminated
Initiated: 2001-10-19
Posted: 2003-10-15
Terminated: 2004-05-11
Recalling firm: Cordis Neurovascular, Inc.
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.
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05

K003925Class IIProwler Infusion Catheters with Pre-Shaped TipsCordis Neurovascular, Inc. / cleared 2001-01-08

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)