Z-1270-2022Class II

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Name: Z-1270-2022 Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Creator: Volcano Corp
Published: 2022-05-16
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2022-05-16 / Terminated / root cause: sterility

FDA source

Volcano Corp began a recall of Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 on 2022-05-16. FDA classified it as Class II and gives the reason as "Due to a potential failed sterilization process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1270-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-16
Posted: 2022-06-16
Terminated: 2024-12-23
Recalling firm: Volcano Corporation
Product: Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Product code: DXQ Blood Pressure Cuff
Reason for recall: Due to a potential failed sterilization process.
Root cause tag: sterility
FDA root cause: 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: [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
Quantity in commerce: 11 devices
Distribution: U.S.: WA and WI O.U.S.: Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1270-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1270-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-22	2022-06-16

Product code DXQ

K202543Class IIOmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation / cleared 2020-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)