FDAFDA · Food and drugs·Recall number Z-0506-2018
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Published February 14, 2018 · Recall initiated: September 14, 2017
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
Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiovascular Systems Inc
- Distributor
- FL, IL, MI, MN, MO, NY, SC, TX, and WI
- Lot
- Lot # 190217 Part #: 7-10011 Model # DBP-150SOLID145
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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