Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
Given Imaging Ltd. · Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruct…
- Status
- Ongoing
- City
- Yokne'Am Ilit
- Country
- Israel
- Classification
- Class I
- Product type
- Devices
- Event ID
- 99626
- Recalling firm
- Given Imaging Ltd.
- Address 1
- New Industrial Park
- Address 2
- 2, Hacarmel St.; Ta Do'Ar 258
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Recall number
- Z-3090-2026
- Product quantity
- 127,416
- Recall initiation date
- 20260806
- Center classification date
- 20260910
- Report date
- 20260916
- Distribution pattern
Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.
- Product description
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.
- Reason for recall
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
- Code info
Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)