FDAFDA · Food and drugs·Recall number Z-1016-2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Published May 4, 2022 · Recall initiated: February 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Freudenberg Medical, Llc
- Distributor
- US distribution: GA, OH Foreign distribution: Netherlands
- Lot
- Lot Numbers: PD01, PD00013140 UDI: 00850004312001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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