The Recall Desk

FDA (Devices) recall action 73882

Covidien LLC recalled 2 products on 2016-05-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-05-18
Critical
0
Units
14,200

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2016-05-18

    Recall of Given Imaging Bravo pH Capsule Delivery Devices

    Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.

    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 Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and chi
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-05-18

    FDA Recalls Given Imaging Bravo pH Capsule Delivery Device

    FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.

    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 c
    Category
    Distribution
    0 states