Recall Z-1270-2022
Volcano Corp · initiated May 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Codes / 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
Reason for recall
Due to a potential failed sterilization process.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-1270-2022
- Initiated
- May 16, 2022
- Terminated
- December 23, 2024
- Product code
- DXQ – Blood Pressure Cuff
- Quantity
- 11 devices
- Distribution
- U.S.: WA and WI O.U.S.: Canada
- Recalling firm
- Volcano Corp, San Diego, CA