FDA recall Z-2224-2021

Integra LifeSciences Corp. · Class II · device

Product

CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037

Reason for recall

Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier

Distribution

US Nationwide Distribution - Foreign Distribution: Hong Kong

Key facts

Status
Terminated
Initiation date
2021-06-01
Report date
2021-08-18
Termination date
2023-01-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2224-2021