Why in 2013 was there
Product recalls can have a potentially devastating impact on medical device manufacturers. Obviously, the cost of a recall can be high, but it can also shake customer loyalty.
Here is a recap of the facts for 2013:
- A total of 1,138 recalls were published by the FDA’s Enforcement Report
- This represents a 9% increase from 2012
- The previous high was 1,046 reported in 2012
- In 2011, there were 957 recalls
Ann Ferriter, director of the Division of Analysis and Program Operations from the CDRH’s Office of Compliance, states that once a company has been cited by the FDA for failing to report a recall – or not reporting in a timely fashion – they tend to be more proactive in reporting everything that might be considered a correction or removal. They tend to
She also claims that manufacturers of certain devices tend to
Ferriter maintains that if you eliminate the over-reporting after being cited and the AED, ventilators, radiological
Are you concerned about the increase in product recalls is on an upward trend? Or do you agree with the FDA’s explanation of the increase? Please share your thoughts with us.
Photo Credit: Ari Herzog