Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH
This recall has been terminated (originally issued May 9, 2003).
- Company
- Medtronic, Inc.
- Recall Initiated
- March 17, 2003
- Posted
- May 9, 2003
- Terminated
- February 19, 2008
- Recall Number
- Z-0800-03
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
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.
Distribution
AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
Lot / Code Info
Lot Number: 122596
Root Cause
Other
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.
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