You may have seen the press reports of Covidien’s recall of its Roticulator in the past few days. If not, have a look here to see MassDevice’s take on the situation. What seems to have occurred is that the global behemoth has identified, during routine internal inspection, that packaging breaches may have either happened or that the packaging is vulnerable to breach.
Consequently the company has issued a global recall announcement relating to two models of its Roticulator 55 and three models of the Roticulator 30 single-use staplers and stated, as far as we can see only to MassDevice, that it wants health providers to identify and quarantine all affected devices for return to the company.
What’s equally interesting is the fact that this global news has not touched the Covidien website nor the FDA’s recall pages nor even the UK MHRA’s own alert pages, begging the question, is there a sterility problem or not?
The company apparently said it’s not issuing a press release because the incident is “not material”, so is presumably pretty relaxed about the affair. But not relaxed enough to do nothing about it and indeed is choosing to incur the huge cost and inconvenience of recalling presumably thousands of these things from around the world.
It’s one of those grey areas. The company sees the appointment of a new VP and Treasurer(most recent press release issued yesterday) as being more important than telling the world of a risk that a supposedly sterile device in daily use is potentially not sterile.
One could be forgiven for suggesting that this might be one of those moments when the regulators need to make the call about whether a problem is material or not, because one would have thought a recall was important enough by definition to want to communicate it as broadly as possible.
Source: MassDevice, medlatest staff
published: May 23, 2012 in: Covidien, General Surgery, Gynaecology/Obstetrics, medlatest Editorial, Recalls, Thoracic/Respiratory