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Product is labeled as Cordis Pre-shaped Prowler Plus MP… recallZ-0018-04 · Cordis Neurovascular, Inc. · initiated Oct 19, 2001

Terminated All recalls posted in October 2003

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cordis Neurovascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0018-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 19, 2001
Posted by the FDA
Oct 15, 2003
Recalling firm
Cordis Neurovascular, Inc.
Quantity
54
FDA submissions
K003925
Distribution
Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.

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.

Code information (models, lots, serial numbers)

Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05

Other devices under the same FDA submission

8 devices cleared under K003925 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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