Recall Z-1270-2022 ยท DXQ Blood Pressure Cuff
Volcano Corp
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
| Date | May 16, 2022 |
| Status | Terminated |
| Reason | Due to a potential failed sterilization process. |
| 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 wit |
| Quantity | 11 devices |
| Distribution | U.S.: WA and WI O.U.S.: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip Volcano Corporation, Sep 28, 2020 |