The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.
Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.
The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.
Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.
Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.
Methanol,a highly toxic type of alcohol, can cause serious and sometimes fatal damage if ingested by humans or animals.
The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.
Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity
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