Reported Jul 6, 2016 · Terminated
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number…
Cardiovascular Systems 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: Cardiovascular Systems Inc · 1225 Old Hwy 8 NW · Saint Paul, MN · 55112-6416
Is this the product you have?
- 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 Diamondback 360. Cardiovascular.
- Lot codes and dates
- Lot #160877
- UDI Number(01)10852528005084(17)180430(10)160877
- Amount recalled
- 190 units (38 - 5 pack shelf cartons)
Where it was sold
- Nationwide
Why it was recalled
The pouch label was missing the use by date (UBD) of 2018-04.
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.
Free recall alerts
Get alerted about new Cardiovascular Systems Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.