Ikaria recalls Mallinckrodt INOflo DS devices with incorrect expiration date programming in Lot 17FP-0570. The INOmeter may display expired gas if not updated properly.
INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct expiration date noted (11/2020).
Ikaria is recalling Mallinckrodt's INOflo DS nitric oxide delivery devices with Lot 17FP-0570 serial numbers due to incorrect expiration date programming. This could cause the device to stop delivering gas when the expiration date is past, potentially leading to unsafe treatment.
The INOmeter is programmed with an incorrect expiration date (11/2017) instead of the actual expiration date (11/2020). When the device detects the expiration date is past, it stops gas delivery after 120 seconds, which could interrupt treatment.
Healthcare providers using the specific Lot 17FP-0570 INOflo DS devices with the listed serial numbers. Patients receiving nitric oxide therapy are at risk if the device stops delivery unexpectedly.
Check for the Lot 17FP-0570 serial numbers listed in the recall notice. The INOmeter is attached to the INOflo cylinder and displays the expiration date.
Look for the specific serial numbers listed in the recall notice (e.g., QL15110251) on the INOflo cylinder.
Confirm the expiration date on the INOflo cylinder label is 11/2020, not 11/2017 as programmed.
The INOmeter was programmed with an incorrect expiration date (11/2017) instead of the actual expiration date (11/2020) for Lot 17FP-0570 devices.
The device stops gas delivery after 120 seconds if it detects the expiration date is past, which could interrupt treatment.
Check if your INOflo cylinder has a Lot 17FP-0570 serial number from the list provided in the recall notice.
We’ve drafted a message you can send Ikaria to request your refund or repair — edit it as you like.
Subject: Recall Z-2733-2018 — Ikaria Ikaria Hello, I own a Ikaria that is covered by recall Z-2733-2018 from Ikaria. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
