Recall Z-1270-2022— Volcano Corp

Name: FDA recall Z-1270-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-16

Class II · Terminated

Class II FDA medical device recall by Volcano Corp, initiated 2022-05-16, terminated 2024-12-23. It names one FDA 510(k) clearance: K202543. Product: Philips OmniWire Pressure guide wire REF 89185J PN 300000252891. Reason: Due to a potential failed sterilization process..

Recalling firm: Volcano Corp
Classification: Class II
Status: Terminated
Initiated: 2022-05-16
Terminated: 2024-12-23
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation·cleared 2020-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Reason for recall

Due to a potential failed sterilization process.

Data sourced from openFDA. This site is unofficial and independent of the FDA.