FDA Device

Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602.

Hazard

The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.

What You Should Do

Remedy

The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.

Products

Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602.
Brand
Ross Products Division Abbott Laboratories
UPC
Lot Numbers: 73088GZ00, 75182GZ00, 78309GZ00, 72040GZ00, 75183GZ00, 77269GZ00, 79340GZ00, 79365GZ00.