Summary
The FDA issued a Class II for Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 by Volcano Corp. Reason: Due to a potential failed sterilization process..
Details
Source
Device Recall
External ID
Z-1270-2022
Action Date
2022-06-22
Status
Terminated
Category
device
Product Description
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Lot/Code Info: Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719
Quantity Affected: 11 devices
Reason for Recall
Due to a potential failed sterilization process.
Distribution
U.S.: WA and WI O.U.S.: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-16
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 108 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Volcano Corp has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volcano Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volcano Corp have FDA actions?
Volcano Corp has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1270-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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