FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH
Brand
Medtronic, Inc.
UPC
Lot Number: 122596