Class II — Freudenberg Medical, Llc
| Recalling firm | Freudenberg Medical, LLC |
|---|---|
| Registered facility | FREUDENBERG MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia |
| Product | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) |
| Quantity | 8 units (OUS) |
| Distribution | US distribution: GA, OH Foreign distribution: Netherlands |
| Initiated | 2022-02-21 |
| Classified | 2022-04-28 |
| Terminated | 2024-04-18 |
| Recall number | Z-1017-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Freudenberg Medical, Llc (Z-1017-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89882/
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