Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
FDA Recall Z-0909-2023 · Posted 2023-01-06
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusOpen, Classified
Product CodeHBA
Date Initiated2022-12-02
Product Quantity168 US; 3 OUS
Reason for Recall
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.
Firm Action
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: [email protected]
Root Cause
Process control
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.
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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