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U.S. Department of Health and Human Services

Class 2 Device Recall OmniWire Pressure guide wire

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  Class 2 Device Recall OmniWire Pressure guide wire see related information
Date Initiated by Firm May 16, 2022
Create Date June 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-1270-2022
Recall Event ID 90292
510(K)Number K202543  
Product Classification blood pressure cuff - Product Code DXQ
Product Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Code Information 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
Recalling Firm/
Manufacturer		 Volcano Corp
3721 Valley Centre Dr Ste 500
San Diego CA 92130-3328
For Additional Information Contact Emily Dentler
619-380-1318
Manufacturer Reason
for Recall		 Due to a potential failed sterilization process.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 16, 2022, Philips sent an "URGENT Medical Device Recall" Letter via email to Philips Sales Representatives who then delivered directly to the affected customer. The Letter informed customers that between 05/04-12/2022, potentially non-sterile products were shipped to customers. Customer are asked to immediately check their product inventory and quarantine any affected products to prevent use. Affected product is requested to be returned to Philips IGTD for replacement products. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: igtdc.r@philips.com For further information or support concerning this issue, contact the local Philips representative: Philips IGTD Customer Service: Phone: 1-800-722-9377, Option 1 Email: IGTD.CustomerInquiry@philips.com Hours of Operation: Monday - Friday 8:00AM 5:00PM PST
Quantity in Commerce 11 devices
Distribution U.S.: WA and WI O.U.S.: Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXQ and Original Applicant = Volcano Corporation
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