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.
Recall
- Recall Number
- Z-0018-04
- Event Number
- 26334
- Firm
- Cordis Neurovascular, Inc.
- FEI Number
- 1000222137
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 19, 2001
- Posted
- October 15, 2003
- Terminated
- May 11, 2004
- Address
- 14000 NW 57th Ct., Miami Lakes, FL, 33014
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.
These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
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.
Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
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