AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Recall
- Recall Number
- Z-2331-2024
- Event Number
- 94804
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- GWG
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- June 7, 2024
- Posted
- July 11, 2024
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650
Description
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter, dated 6/7/24, was mailed to consignees. The notification instructs consignees to immediately remove any affected devices from service and place them in quarantine. The recall notification is to be forwarded to users of the product within your facility for their awareness. Consignees are to complete the provided response form and return it via email to [email protected] or by fax to 1-609-750-4220. Integra Customer Service will reach out to consignees regarding a Return Materials Authorization and return directions upon receipt of the response form. Consignees with any questions are to contact Customer Service from 8:00 AM to 8:00 PM from Monday to Friday by phone at 1-800-654-2873 or by email at [email protected]
Domestic: NY, OH, & DC.
14 units