Product Safety Recalls

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Freudenberg Medical, Llc Recall 89882

Description: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

Freudenberg Medical, Llc Recall 89882 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1016-2022
Event ID89882
Event DescriptionEmpower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Product TypeDevices
DistributionUS distribution: GA, OH Foreign distribution: Netherlands
Quantity13 units (US)
Recall ReasonNon-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Device Classification20220504
Device Code InfoLot Numbers: PD01, PD00013140 UDI: 00850004312001
Center Classification Date20220428
Recall Initiation Date20220221
Recalling FirmFreudenberg Medical, Llc
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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