Z-1619-2016 Class II Terminated
FDA device recall Z-1619-2016 was initiated by Covidien LLC on Apr 15, 2016 and is designated Class II. Reason for recall: Potential of an allergic reaction in a patient with nickel sensitivity. The recall status is terminated (terminated Jul 13, 2017). Affected quantity: 12,895 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2016
- Initiation Date
- Apr 15, 2016
- Termination Date
- Jul 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,895 units
Product Description
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 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.
Reason for Recall
Potential of an allergic reaction in a patient with nickel sensitivity.
Distribution Pattern
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.
Code Information
All lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1619-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026