Z-1016-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- February 21, 2022
- Termination Date
- April 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units (US)
Product Description
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
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 Pattern
US distribution: GA, OH Foreign distribution: Netherlands
Code Information
Lot Numbers: PD01, PD00013140 UDI: 00850004312001