FDAFDA · Food and drugs·Recall number Z-1556-2022
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Published August 24, 2022 · Recall initiated: June 30, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Outer carton packaging of microcatheters were exposed to wet substance during transport.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro Therapeutics, Inc.
- Distributor
- US Nationwide Distribution: None OUS: Brazil
- Lot
- Lot # B177543 UDI: (00) 847536006270
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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