Recall Effectiveness - Accessory to Medical Devices shipped through Distributors

Jkc3usc12

Involved In Discussions
#1
Not sure if this is the correct thread to ask.

Company has issued a recall for an accessory to a medical device. All medical devices have been shipped through a distributers. The distributors only track the device not the accessory. So they have locations of the device just not serial number which accessory it went with.

They have been notified but the response forms I am getting back about the notification state they checked their inventory but all others they don't track. So nothing more has been done.

If its in our contract that they track serial numbers and notify customers, is there anything more I can do?

Thanks
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
That's some unpleasant business.
Is this a Capital R Recall, or more of an advisory where you're willing to take an affected product back?

Some things to be clear on-
This is an accessory to a medical device and is not listed in and of itself?
Will the device(s) that this accessory is used in not function if this accessory fails?
Could patients be in danger if this accessory fails, perhaps causing a failure of the device or creating contamination, etc.
 

Jkc3usc12

Involved In Discussions
#3
Considered a class 2 recall. We have contacted all distributors.

There is some risk to the patient. There have been not reported injuries or harm.

The problem is again they have sold all product and do not track the serial numbers on this accessory.

if the product fails you will not be bale to use.
Our own investigation show less than 10% would have been affected. The fix is a simple check and if missing the part it can sent to replaced.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Considered a class 2 recall. We have contacted all distributors.

There is some risk to the patient. There have been not reported injuries or harm.

The problem is again they have sold all product and do not track the serial numbers on this accessory.

if the product fails you will not be bale to use.
Our own investigation show less than 10% would have been affected. The fix is a simple check and if missing the part it can sent to replaced.
Since it's not a device itself and you have contacted your distributors it's now up to them to pass the information on to their customers.

Sounds like you have done you part. I would follow up with all distributors to make sure they got the notice. Even asking for them to respond via email so you can have a log of who responded and who didn't.
If they choose not to act on it there's not a whole lot you can do unless they share their customer lists with you to notify users directly.
 
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