Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Recall
- Recall Number
- Z-1270-2022
- Event Number
- 90292
- Firm
- Volcano Corp
- FEI Number
- 3008363989
- Product Code
- DXQ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 16, 2022
- Terminated
- December 23, 2024
- Address
- 3721 Valley Centre Dr, Ste 500, San Diego, CA, 92130-3328
Description
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Due to a potential failed sterilization process.
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
U.S.: WA and WI O.U.S.: Canada
11 devices