Recall Z-1619-2016
Covidien LLC · initiated April 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: All lot numbers
Reason for recall
Potential of an allergic reaction in a patient with nickel sensitivity.
FDA-determined cause: Device Design
Action taken
The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/2016 to its Customers via Federal Express. The letter describes the product, problem and actions to be taken.The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance MITGFCA@Covidien.com or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo pH monitoring system User Manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. "The Bravo capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. The Bravo pH test lasts from 48-96 hours." If you have any questions, please contact Technical Service at 1-800-448-3644, option 3.
Details
- Recall number
- Z-1619-2016
- Initiated
- April 15, 2016
- Posted by FDA
- May 6, 2016
- Terminated
- July 13, 2017
- Product code
- FFT – Electrode, Ph, Stomach
- 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.
- Recalling firm
- Covidien LLC, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1620-2016 Class II | Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH…Potential of an allergic reaction in a patient with nickel sensitivity. | 04/15/2016Terminated |