Reported Feb 19, 2020 · Terminated
Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The…
Microvention, Inc.
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: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601
Is this the product you have?
- Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA
- Distributed ByTerumo Medical Corporation, Somerset, NJ; Made in Costa Rica
- Lot codes and dates
- Catalog/lot numbers
45-651026 - 19030655Y19041556Wand 19051058Aand 45-652050 - 19030654Y and 19041556X
- Catalog/lot numbers
- Amount recalled
- 19 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The devices may be missing the implant coil.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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