FDA recall Z-0909-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-12-02

Report date

2023-01-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2023