🔍 RecallPedia

Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.

Class I - Dangerous
🏥 Medical Devices Recalled: July 9, 2018 INO therapeutics LLC/dba ikaria Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Drug Product Lot: 17FP-0570: Serial Numbers: QL15110251 QL10110347 QL10110129 QL14110221 QL15030431 QL16090656 QL10060287 QL10110899 QL13050382 QL14110580 QL15030433 QL16090682 QL11100366 QL10110640 QL13060172 QL14110183 QL15030239 QL16090726 QL10110167 QL11100211 QL11090274 QL14110364 QL15040218 QL16090216 QL11100120 QL10101263 QL11090302 QL14120583 QL15030268 QL16090578 QL08030908 QL10070478 QL11090309 QL14120592 QL15030287 QL16090742 QL10110845 QL11090396 QL13060801 QL15020176 QL15030302 QL16090839 QL10110487 QL10111032 QL13061068 QL14120190 QL15030305 QL17060229 QL10020777 QL10110878 QL13061305 QL14120207 QL15110453 QL17060244 QL10110981 QL11090364 QL13110288 QL14110239 QL15110515 QL17060339 QL10070487 QL11090353 QL13110607 QL14110273 QL15110565 QL17060408 QL10100716 QL04100498 QL14050878 QL14110348 QL15110566 QL17060433 QL10101152 QL10070427 QL14060106 QL15010810 QL16090250 QL17060447 QL10060228 QL10110293 QL14060244 QL15010831 QL16090265 QL17060453 QL08031575 QL10060326 QL10110842 QL15011726 QL16090266 QL17060522 QL10070686 QL10110319 QL13110100 QL15010742 QL16090439 QL17060525 QL10060315 QL10110682 QL14110251 QL15030223 QL16090650 QL17090297 QL10111117 QL13050250 QL14110539 QL15030248 QL16090654 QL17090334
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
INO therapeutics LLC/dba ikaria
Reason for Recall:
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.

Product Codes/Lot Numbers:

Drug Product Lot: 17FP-0570: Serial Numbers: QL15110251 QL10110347 QL10110129 QL14110221 QL15030431 QL16090656 QL10060287 QL10110899 QL13050382 QL14110580 QL15030433 QL16090682 QL11100366 QL10110640 QL13060172 QL14110183 QL15030239 QL16090726 QL10110167 QL11100211 QL11090274 QL14110364 QL15040218 QL16090216 QL11100120 QL10101263 QL11090302 QL14120583 QL15030268 QL16090578 QL08030908 QL10070478 QL11090309 QL14120592 QL15030287 QL16090742 QL10110845 QL11090396 QL13060801 QL15020176 QL15030302 QL16090839 QL10110487 QL10111032 QL13061068 QL14120190 QL15030305 QL17060229 QL10020777 QL10110878 QL13061305 QL14120207 QL15110453 QL17060244 QL10110981 QL11090364 QL13110288 QL14110239 QL15110515 QL17060339 QL10070487 QL11090353 QL13110607 QL14110273 QL15110565 QL17060408 QL10100716 QL04100498 QL14050878 QL14110348 QL15110566 QL17060433 QL10101152 QL10070427 QL14060106 QL15010810 QL16090250 QL17060447 QL10060228 QL10110293 QL14060244 QL15010831 QL16090265 QL17060453 QL08031575 QL10060326 QL10110842 QL15011726 QL16090266 QL17060522 QL10070686 QL10110319 QL13110100 QL15010742 QL16090439 QL17060525 QL10060315 QL10110682 QL14110251 QL15030223 QL16090650 QL17090297 QL10111117 QL13050250 QL14110539 QL15030248 QL16090654 QL17090334

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2733-2018