FDAFDA · Food and drugs·Recall number Z-0205-2015
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Published November 19, 2014 · Recall initiated: October 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Medtronic Vascular
- Distributor
- US Distribution including the states of NC, IA, IL and KS.
- Lot
- Lot Number: 0007244836 MODEL: LA6JR40K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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