—#26597

Product

Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH

510(k) numbers: K981198
Affected lot / code info: Lot Number: 122596

Why it was recalled

The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.

Root cause (FDA determination)

Other

Action the firm took

Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.

Recalling firm

Firm: Medtronic, Inc.
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary

Timeline

Recall initiated: 2003-03-17
Posted by FDA: 2003-05-09
Terminated: 2008-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.