FDA Recall
Terminated
Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
Recall: Z-0800-03
·
Initiated March 17, 2003
Recall
- Recall Number
- Z-0800-03
- Event Number
- 25847
- Firm
- Medtronic, Inc.
- FEI Number
- 1220452
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 17, 2003
- Posted
- May 9, 2003
- Terminated
- February 19, 2008
- Address
- 35-37A Cherry Hill Drive, Danvers, MA, 01923-2565
Description
Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
Reason
The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
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.
Distribution
AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary