Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Dutch Food and Consumer Product Safety Authority on 30th May, 2017, recalled Heartmate II LVAS Pocket System Controller due to risk of patient injury and/or death during backup controller exchange.

The Heartmate II LVAS Pocket system controller is a power supply that connects to the implanted Heartmate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system. The Heartmate II LVAS System is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.The pocket System controller is provided to each patient for use in case of a device alarm or malfunction. Change to backup system controller should be done quickly and in the hospital to avoid risk of serious injury or death.

The details of the product are as follows:

Heartmate II Left Venticular Assist (LVAS) Pocket System Controller

Model/Item Numbers:           105109, 106015, 106762, 107801

Manufacturing Dates:             July 2012 to March 2017

Distribution Dates:                 July 2012 to March 2017

A total of 70 reports of incidents in which the controller has malfunctioned after an exchange including nineteen (19) injuries and twenty-six (26) deaths have so far been received by the manufacturer. All the deaths occurred when the patients attempted to exchange controllers while away from the hospital.

 Healthcare provider’s action

  • Healthcare providers treating patients with left ventricular heart failure using the Heartmate II LVAS Pocket system Controller should be aware of this risk and also communicate the same to their patients with Heartmate II LVAS System Controller. This will help prevent health risks associated with the use of the device.
  • Healthcare providers and patients should report adverse events associated with the use of this system to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC……..Safeguarding the Health of the Nation!!!

The National Agency for Food and Drug Administration and Control has been notified that the British Medicines and Healthcare Products Regulatory Agency (MHRA) have announced the global recall of various High Concentration Oxygen Masks manufactured by ConvaTec and Unomedical. High Concentration Oxygen Masks are intended to deliver high concentration oxygen to patient airways.

Reason for recall

  •  Product reports confirmed that the devices are not meeting the desired expectation.
  •  In some cases, the tubing was found to be disconnecting from the oxygen mask, prior to use or during use causing disruption in oxygen supply.

The details of the affected batches are as follows;

Manufacturer’s Address: ConvaTec Limited, First Avenue, Deeside Industrial Park,

                                            Deeside, CH5 2NU, U.K.

Product Code / REF No. SAP Code Description LOT No's.
104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631

106MM

1702436

Oxygen Mask, Adult High Concentration Non-Rebreather 2.1m (7') Oxygen Tubing

100733,104106,104798,100721,109824

108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

102766,102785,102726,102352,105451,

109186

108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

100281,100709,100729,101923,103180,

103265,103691,103714,104104,105987,

110558

3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 102727
3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 100720,101141
3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 104906,105181
9108MM 126152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

100232,100694,100918,101639,101897,

103067,104846,104848,105453

       

Healthcare Provider’s Action

  • Healthcare providers in possession of these affected products should stop using them.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC……..Safeguarding the Health of the Nation!!!

The National Agency for Food and Drug Administration and Control has been notified by the U.S. Food and Drug Administration (U.S. FDA) of its approval of label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.

These general anesthetic and sedation drugs are necessary for surgery or other painful and stressful procedures in patients including infants, children and pregnant women. They are administered intravenously or by inhalation to render a patient reversibly unconscious and unresponsive in order to allow surgeons operate on the patient.

The label changes include the following warnings;

  • Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
  • Exposure to the use of these medicines on pregnant and pediatric patients for more than 3 hours can cause widespread loss of nerve cells in the developing brain. Studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

Healthcare Provider Action

  • Continue to ensure patients counseling and discussion on the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs.
  • Parents, caregivers and pregnant women should be encouraged to ask questions on their concerns about these medicines.
  • Healthcare providers as well as patients are encouraged to report adverse events or side effects related to the of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC.........Safeguarding the Health of the Nation!!!

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