Z-0909-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- December 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168 US; 3 OUS
Product Description
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
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 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.
Code Information
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027