Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 due to potential failed sterilization. Affected units have specific serial numbers and part numbers.
Due to a potential failed sterilization process.
Volcano Corp has recalled Philips OmniWire Pressure guide wire model 89185J with part number 300000252891 because of a potential failed sterilization process. This could lead to contamination risks during medical procedures.
The device may not have been properly sterilized during manufacturing, which could lead to contamination. This poses a risk of infection or other complications during medical procedures if the device is used without proper sterilization.
Healthcare professionals using this specific medical device are most at risk. Patients receiving procedures with this device may be affected if the sterilization process failed.
Check for serial numbers 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, or 37719. The product has a specific part number 300000252891 and model number 89185J.
Look for serial numbers 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, or 37719 on the device.
The recall is due to a potential failed sterilization process, which could lead to contamination risks during medical procedures.
Check the serial numbers listed in the recall notice to see if your device is affected. If it is, you should stop using it and contact Volcano Corp for further instructions.
The recall notice does not specify a deadline for action, but you should check the serial numbers and stop using the device if it is affected.
We’ve drafted a message you can send Volcano Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-1270-2022 — Volcano Corp Volcano Corp Hello, I own a Volcano Corp that is covered by recall Z-1270-2022 from Volcano Corp. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
