FDA recall Z-1017-2022

Freudenberg Medical, Llc · Class II · device

Product

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Reason for recall

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

Distribution

US distribution: GA, OH Foreign distribution: Netherlands

Key facts

Status
Terminated
Initiation date
2022-02-21
Report date
2022-05-04
Termination date
2024-04-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jeffersonville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2022