Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: Recalled by Freudenberg Medical, Llc Due to Non-intended glue from the hub/shaft bond on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Freudenberg Medical, Llc directly.
Affected Products
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Quantity: 8 units (OUS)
Why Was This Recalled?
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Where Was This Sold?
This product was distributed to 2 states: GA, OH
About Freudenberg Medical, Llc
Freudenberg Medical, Llc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report