Integra LifeSciences Corp.: Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Hazard

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.

Details from the source

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. Distribution: 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. Quantity: 168 US; 3 OUS Lot/code info: UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

UPC codes

10381780514961

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.