Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1620-2016

U.S. FDA — Device Enforcement · United States · 2016-04-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1620-2016
Date of alert: 2016-04-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Covidien LLC
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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