Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH
FDA device recall Z-0799-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Medtronic, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Distribution
- AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
- Date initiated
- 2003-03-17
- Date posted
- 2003-05-09
- Date terminated
- 2008-02-19
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC ZUMA GUIDING CATHETER (K981198) | Medtronics Interventional Vascular | 1998-08-07 |