Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Missing Date
Cardiovascular Systems Inc is recalling ViperWire Advance Peripheral Guide Wire because the pouch label was missing the use-by date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a missing use-by date on the label, which is a documentation and packaging issue without reported injuries or illnesses.
Plain-English summary
Cardiovascular Systems Inc is recalling 190 units of ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide. The affected product is identified by Part number 72023-02, Model Number VPR-GW-17, and Lot #160877. The recall involves five guide wire pouches in one guide wire box, intended for use with CSI Peripheral Orbital Atherectomy Devices.
The recall was initiated because the pouch label was missing the use-by date of 2018-04. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected guide wires and contact Cardiovascular Systems Inc for instructions on return or replacement.
The recalled product
- Product
- ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and…
- Manufacturer
- Cardiovascular Systems Inc
- Category
- Medical Device — Cardiovascular
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #160877
- UDI Number: (01)10852528005084(17)180430(10)160877.
Distribution
Distributed nationwide across the United States.
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