Covidien LLC recalls Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Ite

Recalled May 18, 2016 · FDA recall Z-1620-2016 · Covidien

Hazard

Potential of an allergic reaction in a patient with nickel sensitivity. · FDA Class II

Units

1,305 units

Sold at

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.

Description

Potential of an allergic reaction in a patient with nickel sensitivity.

Product

Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

Manufacturer(s)

Covidien LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →