FDAClass IIMay 18, 2016

Given Imaging Bravo¿ pH capsule delivery device recall

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…

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 numbers

Product
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…
Recalling firm
Covidien LLC
Quantity
12,895 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)
Open FDA enforcement record Latest recalls