Device product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Z-0909-2023
Product summary
- Event
- Event 91280
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 168 US; 3 OUS
- Official record key
device-enforcement:Z-0909-2023
Official wording
Reason: 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.
Code information: UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
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.
Derived failure modes
-
Potency or specification failure
out-of-specification