AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
FDA Recall Z-2331-2024 · Posted 2024-07-11
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusOpen, Classified
Product CodeGWG
Date Initiated2024-06-07
Product Quantity14 units
Reason for Recall
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Firm Action
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]
Root Cause
Process change control
Distribution Pattern
Domestic: NY, OH, & DC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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