medical Class II Updated 2022-05-04

Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56

Recalled Product

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Hazard / Issue

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

Issued by

FDA

Affected States: GA, OH
Lot/Code Info: Lot Numbers: PD02, PD00013142 UDI: 00802526618000
View official government recall

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