Peripheral Diamondback 1.25 Solid OAD recall: Labeling Error
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive…
Why was Peripheral Diamondback 1.25 Solid OAD recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145
- Product
- Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive…
- Recalling firm
- Cardiovascular Systems Inc
- Quantity
- 8
- Distribution
- FL, IL, MI, MN, MO, NY, SC, TX, and WI
- Recall date
- February 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)