Recall Z-2331-2024
Integra LifeSciences Corp. · initiated June 7, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Codes / lots: Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Reason for recall
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
FDA-determined cause: Process change control
Action taken
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 FCA3@integralife.com 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 custsvcnj@integralife.com
Details
- Recall number
- Z-2331-2024
- Initiated
- June 7, 2024
- Posted by FDA
- July 11, 2024
- Product code
- GWG – Endoscope, Neurological
- Quantity
- 14 units
- Distribution
- Domestic: NY, OH, & DC.
- Recalling firm
- Integra LifeSciences Corp., Princeton, NJ