Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo p
FDA device recall Z-0966-2012 · posted 2012-02-06 · Terminated
Recall details
- Recalling firm
- Given Imaging Ltd.
- Reason for recall
- Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
- Action taken
- Given Imaging sent a Urgent Product Recall letter to all affected consignees. The letter identified the product, description of problem, actions to be taken and advised customers to read this important information packet in its entirety. Customers were advised to complete the Customer Response Sheet included and return per the instructions provided. Also attached to the letter was a Customer Bulletin: Update to Vacuum Settings. For questions call 1-800-448-3644 option 3.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LLT
- Quantity affected
- 21,885 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Austria, Belgium, Brazil, Denmark, Canada, Cyprus, Finland, Germany, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Netherlan
- Date initiated
- 2012-01-11
- Date posted
- 2012-02-06
- Date terminated
- 2012-09-14
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543) | Given Imaging , Ltd. | 2010-12-01 |