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Terminated

Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH

FDA Recall Z-0800-03 · Posted 2003-05-09

Recalling FirmMedtronic, Inc.
Recall StatusTerminated
Date Initiated2003-03-17
Date Terminated2008-02-19

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981198MEDTRONIC ZUMA GUIDING CATHETERMedtronics Interventional Vascular · 1998-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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