How do Blood and Plasma Products get recalled?
Generally, a recall is a product that is removed from the market or a correction made to the product because it is either defective or potentially harmful. A recall is usually a voluntary act urged on by the manufacturers.
In serious cases, however, blood and plasma recalls may occur as a responsible way to protect the public health from products that present a risk of injury or serious defect.
What happens when blood or plasma products get recalled?
A blood and plasma recall may involve either a withdrawal (addresses a problem to remove products that present only minor or unknown risks) or removal (addresses a problem that results in the removal completely at the manufacturer’s discretion). The FDA frequently reviews many aspects to assure blood safety.
Once the FDA decides to recalls blood/plasma, it will work with the manufacturer to ensure that the device is taken off the market. In some cases, recalls may be necessary in order to comply with the laws and regulations administered by the FDA.
To know if blood/plasma recall has been issued, you may also check with the Food and Drug Administration (FDA) as it oversees food, drugs as it pertains to public health for consumers. Specifically, consumers can check this website for classified recalls in FDA’s weekly Enforcement Report: http://www.fda.gov/safety/recalls/enforcementreports/default.htm
You may also check with your doctor or healthcare provider. The news media may also make a statement regarding blood or plasma recall. You may also set up alerts on the FDA’s website for various types of recalls also.
Blood or plasma supply is relatively safe due to the safeguards kept in place such as careful screening of blood donors and testing of donated blood to prevent human viruses from getting into the supply. However, since blood can transmit infectious diseases, there is always a risk that blood/plasma becomes contaminated, therefore it is important to ensure that blood and blood products are safe.
What do I do if I have used a recalled blood or plasma product?If you have discovered that a blood or plasma has been recalled, the manufacturer may withdraw the products from the market. Consumers may check with their doctor or hospital to see how they will be impacted.
The Food and Drug Administration (FDA) has jurisdiction on blood and plasma products. It also works in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). In some situations, firms must conduct recalls in a manner specified by FDA. Similarly, the FDA has the authority to order a firm to conduct a recall.