—#197366

Product

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

FDA product code: HBA — Neurosurgical Paddie
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K193346
Affected lot / code info: UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

Why it was recalled

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

Root cause (FDA determination)

Process control

Action the firm took

On December 2, 2022, the firm notified customers via "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letters. Customers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.

Timeline

Recall initiated: 2022-12-02
Posted by FDA: 2023-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.