Freudenberg Medical, Llc Recall: Empower Introducer Sheath with Hydrophilic Coating 21F x
Freudenberg Medical, Llc Recall: Empower Introducer Sheath with Hydrophilic Coating 21F x is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Freudenberg Medical, Llc; Product: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US); Reason for recall: Non-inte
| Recalling firm | Freudenberg Medical, Llc |
|---|---|
| Product | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US distribution: GA, OH Foreign distribution: Netherlands |
| Recall initiated | 20220221 |
| Recall number | Z-1016-2022 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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