Recalls That Should Be On Your Radar—Week of August 5, 2018

We’ve compiled a list of product recalls issued by the US Food and Drug Administration (FDA) from this past week.

Arkon Anesthesia Delivery System Recalled Due to Unexpected Failed State While in Use or Idle

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor (anesthesia that can be inhaled) with a dismountable vaporizer.

Read the full recall information.

G&C Raw, LLC Recalls Pet Food Potentially Contaminated with Listeria Monocytogenes

G & C Raw, of Versailles, OH is recalling 30 1—lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria can cause serious and sometimes fatal infections in animals eating the products. Infected animals can shed Listeria monocytogenes through their feces onto their coats and into the home environment, and thus, serve as sources of infection to humans.

Furthermore, there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after contact with the products or any surfaces exposed to these products.

For more information on this recall, consult the official statement.

Camber Pharmaceuticals, Inc. Issues Recall of Valsartan Tablets Due to Trace Amount of NDMA Impurity

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40 mg, 80 mg, 160 mg and 320 mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit — I (API manufacturer).

Valsartan Tablets, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30 ct bottles & 90 ct bottles.

In July, the FDA sent out a notice alerting health care professionals and patients of a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure.

To learn more about the Camber Pharmaceuticals valsartan recall, read the recall announcement.

To read the FDA’s updated safety alert and see the full list of recalled valsartan products, check out the MedWatch update.

Product Quest Manufacturing LLC Issues Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Potentially Contaminated with Pseudomonas Aeruginosa

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. THolly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

The product is used as a nasal decongestant and is packaged in a 0.5 fluid ounce bottle that is placed in an individual folding carton. 16,896 units were released with UPC code 50428432365. The affected CVS Health 12 Hour Sinus Relief Nasal Mist lot is Lot # 173089J, EXP 09/19.

For additional details on this recall, consult the official announcement.

Qiagen Sciences LLC Recalls AmniSure ROM Test Due to Lack of Control Line Which May Lead to Misinterpretation of Test Results

Qiagen Sciences LLC is recalling the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display. A lack of a control line may lead to misinterpretation of test results. The test is designed to display one line (control line) if the result for the presence of amniotic fluid is negative, and two lines (control line and test result line) if the result for the presence of amniotic fluid is positive. Qiagen Sciences LLC received customer complaints that some tests were not displaying a control line. Failure of a control line to appear leads to an invalid test and delay in obtaining test results due to the need of repeat testing.

In addition, it is possible that the display of a test line in the absence of a control line could be misinterpreted as a negative test when it is a positive test. Inaccurate interpretation of these lab test results can lead to serious adverse events, including fetal deaths and health complications for the mother.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

For more information on this Class 1 recall, consult the medical device recall statement.

Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery

Vyaire Medical, Inc is recalling the AirLife Resuscitation Device due to a manufacturing error which may cause extra plastic material in the oxygen output connection to reduce or block the flow of oxygen to the patient. The blocked connection may result in a delay in or inability to provide necessary ventilation to the patient and potentially result in serious patient injury, such as inadequate oxygen supply (hypoxia), or death. Vyaire has received no complaints of this problem; there have been no patient injuries.

AirLife manual single-use resuscitation devices provide constant ventilation to adults and children who are not breathing or cannot adequately breathe on their own following placement of an advanced airway device (tracheal or tracheostomy tube). To ventilate the patient, a health care provider squeezes the bag causing oxygen to go through a one-way valve to the patient. The bag is released and automatically refills while an exhalation port valve allows for the patient to exhale and the breath is then repeated.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

For additional details on this Class I recall, check out the official announcement.