Freudenberg Medical, Llc Recall 89882
Description: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Freudenberg Medical, Llc Recall 89882 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1016-2022 |
| Event ID | 89882 |
| Event Description | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) |
| Product Type | Devices |
| Distribution | US distribution: GA, OH Foreign distribution: Netherlands |
| Quantity | 13 units (US) |
| Recall Reason | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia |
| Device Classification | 20220504 |
| Device Code Info | Lot Numbers: PD01, PD00013140 UDI: 00850004312001 |
| Center Classification Date | 20220428 |
| Recall Initiation Date | 20220221 |
| Recalling Firm | Freudenberg Medical, Llc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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