Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
- Recall date
- February 21, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1017-2022
- FDA classification
- Class II
- Brand / firm
- Freudenberg Medical, Llc
- Sold / distributed
- US distribution: GA, OH Foreign distribution: Netherlands
Why it was recalled
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Get recall alerts
Free email alert whenever Freudenberg Medical, Llc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Freudenberg Medical, Llc