Reported May 4, 2022 · Terminated
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Freudenberg Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Freudenberg Medical, Llc · 2301 Centennial Blvd · Jeffersonville, IN · 47130-8975
Is this the product you have?
- Empower Introducer Sheath with
- Hydrophilic Coating 21F x 56cm Model668782-200 (OUS)
- Lot codes and dates
- Lot NumbersPD02
- PD00013142 UDI00802526618000
- Amount recalled
- 8 units (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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