Z-1017-2022 Class II Terminated
FDA device recall Z-1017-2022 was initiated by Freudenberg Medical, Llc on February 21, 2022 and is designated Class II. 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 The recall status is terminated (terminated April 18, 2024). Affected quantity: 8 units (OUS).
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
- 8 units (OUS)
Product Description
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 Pattern
US distribution: GA, OH Foreign distribution: Netherlands
Code Information
Lot Numbers: PD02, PD00013142 UDI: 00802526618000