Breaking Medial News, G5 Ventilator by Hamilton: Class I Recall – Ventilation and Alarm Failure

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The ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver). This problem can occur during the following conditions:

  • When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or,
  • When disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other.

If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. For more information visit

 

Safety Labeling Changes posting includes 26 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

The “Summary Page” table provides a listing of product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm471840.htm

The following drugs had modifications to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections:

Atropine Sulfate Injection
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Eloxatin (oxaliplatin) Injection, for Intravenous Use
INOmax (nitric oxide) for Inhalation
Jadenu (deferasirox) Tablets
Letairis (ambrisentan) Tablets
Mirena (levonorgestrel-releasing intrauterine system)
Myfortic (mycophenolic acid) Delayed-release Tablets
Nicoderm CQ (nicotine transdermal system)
Opdivo (nivolumab) Injection
Ortho Evra (norelgestromin and ethinyl estradiol transdermal patch)
Ortho-Novum Tablets (norethindrone/ethinyl estradiol) Tablets and Modicon 28 Tablets (norethindrone/ethinyl estradiol)
Picato (ingenol mebutate) Gel
Pradaxa (dabigatran etexilate mesylate) Capsules
Technnivie (ombitasvir, paritaprevir, and ritonavir) Tablets
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use
Yervoy (ipililumab) Injection

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