Recalls / —

—#208376

Product

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

FDA product code

GWG — Endoscope, Neurological

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K232618

Affected lot / code info

Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.

Why it was recalled

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Root cause (FDA determination)

Process change control

Action the firm took

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

Recalling firm

Firm

Integra LifeSciences Corp.

Address

1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern

Domestic: NY, OH, & DC.

Timeline

Recall initiated

2024-06-07

Posted by FDA

2024-07-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #208376. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.