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Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Recalled May 4, 2022 · FDA recall Z-1017-2022 · Freudenberg Medical
Hazard
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia · FDA Class II
Units
8 units (OUS)
Sold at
US distribution: GA, OH Foreign distribution: Netherlands
Description
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)
Manufacturer(s)
Freudenberg Medical, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →