Class II Recall

A situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote
References in periodicals archive ?
The Class II Recall has been determined to have low health risks.
The VMD wish to make wholesale dealers and veterinary surgeons aware that we have issued a class II recall of the veterinary anaesthetic products:
The recall was designated as a Class II recall, which is defined by the FDA as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
23, 2014) was conducted in response to a Class II Recall of Juice Beauty Illuminating Eye Shadow products that were manufactured there and found to be contaminated with Bacillus cereus, an ocular pathogen that can cause rapidly progressive endophtalmitis and lead to possible loss of vision or the eye.
M2 PHARMA-April 23, 2015-FDA Announces Class II Recall of Zimmer Knee Implant
A Class II recall poses only a temporary health risk, or where the probability of serious adverse health consequences is remote, while Class III means that the product is not likely to cause adverse health consequences.
IARW has been informed by the California Department of Public Health that meat and poultry suppliers, distributors, brokers and processors in the state who sell products that meet the criteria for a Class I or Class II recall according to USDA guidelines must immediately notify the Department of Health and provide the department with a list of customers that have received or will receive product subject to recall.
Boyle told the committee that despite the inhumane treatment of livestock depicted at the Hallmark/Westland plant, the record-setting Class II recall of safe meat products sent a mixed message to consumers, since the meat poses only a minimal health risk.
The US Food and Drug Administration issued a notice on March 12, 2015, for a Class II recall for all lots and sizes of US-based medical device maker Zimmer's Persona Trabecular Metal Tibial Plate knee implant, according to US law firm Seeger Weiss LLP.
A medical device organization undergoes a Class II recall, requiring the removal of approximately 400,000 affected products from the marketplace--200,000 of those out of consumers' homes.
The fact that an animal becomes not ambulatory does not necessarily mean it is ill, said Dopp, who noted that it was "important to note that the government has found no evidence that the meat was unsafe and has appropriately classified it as a 'Class II recall,' and not a 'Class I recall,' which is used when a there is a reasonable probability that a public health risk exists."
This regulation categorizes product recalls into three classifications: A Class I recall means the use of the medical device could result in serious damage to health; a Class II recall implies that use of the medical device could induce temporary or recoverable health damage; and a Class III recall indicates that use of the device generally does not inflict danger to health, and other factors most likely led to the recall.