Recall Z-1620-2016— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2016-04-15, terminated 2017-07-13. It names one FDA 510(k) clearance: K002028. 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.. Reason: Potential of an allergic reaction in a patient with nickel sensitivity..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-15
- Terminated
- 2017-07-13
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential of an allergic reaction in a patient with nickel sensitivity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.