Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Recall Z-1270-2022 · Posted None
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Recalling FirmVolcano Corp
Recall StatusTerminated
Product CodeDXQ
Date Initiated2022-05-16
Date Terminated2024-12-23
Product Quantity11 devices
Reason for Recall
Due to a potential failed sterilization process.
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: [email protected]
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: [email protected]
Hours of Operation: Monday - Friday 8:00AM 5:00PM PST
Root Cause
Under Investigation by firm
Distribution Pattern
U.S.: WA and WI O.U.S.: Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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