FDA Device

Pentalumen TD Thermodilution Catheter, Sterile

Hazard

Thermodilution catheters have a potential for ruptured lumens within the catheter.

What You Should Do

Remedy

Consignees were notified by letter on 11/19/2003.

Products

Pentalumen TD Thermodilution Catheter, Sterile
Brand
Abbott Laboratories HPD/ADD/GPRD
UPC
List No. 41233-01, Lot 04-187-SN

Units Affected

495 units