Given Imaging Bravo¿¿ pH capsule delivery device recall
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…
Why was Given Imaging Bravo¿¿ pH capsule delivery device recalled?
Potential of an allergic reaction in a patient with nickel sensitivity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbrs
- 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…
- Recalling firm
- Covidien LLC
- Quantity
- 1,305 units
- Distribution
- 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.
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)