So, noticed that some units of our medical device were shipped without an NRTL logo. Basically, we used an operator used a draft label.file that did not have the NRTL mark. That's the only issue so I'm not concerned about safety, etc. But, do these units need to be recalled to relabel?
Missing NRTL logo
- Thread starter dr1vn
- Start date
EmiliaBedelia
Quite Involved in Discussions
Your nonconformance/postmarket/recall process should guide you here - it should require you to do some sort of assessment (Health Hazard Evaluation, Health Risk Assessment, etc) to assess the risk associated with the defect and determine whether a recall is necessary. All that should likely be linked to the documentation for the nonconformity and corrective action.
The webpage below has some general info about recalls and the considerations you should take, but this will all depend on what your internal processes say.
www.fda.gov
If you cannot trace any real health risks to the missing label, then you may be able to justify why you don't need to do a recall. But you need to make sure you are following your own procedures and documenting appropriately.
The webpage below has some general info about recalls and the considerations you should take, but this will all depend on what your internal processes say.
Recalls, Corrections and Removals (Devices)
Info related to recall of medical devices, corrections and removals; regulations and Federal Register notices.
If you cannot trace any real health risks to the missing label, then you may be able to justify why you don't need to do a recall. But you need to make sure you are following your own procedures and documenting appropriately.
So, no issues when we ran through our NC and recall work instructions which we'll document in the CAPA. The only thing I can think of is that perhaps this is a violation with the NRTL and that the NRTL would want us to recall and relabel? Personally I think that would introduce more risk and I would not be keen to do that just for a missing logo.Your nonconformance/postmarket/recall process should guide you here - it should require you to do some sort of assessment (Health Hazard Evaluation, Health Risk Assessment, etc) to assess the risk associated with the defect and determine whether a recall is necessary. All that should likely be linked to the documentation for the nonconformity and corrective action.
The webpage below has some general info about recalls and the considerations you should take, but this will all depend on what your internal processes say.
Recalls, Corrections and Removals (Devices)
Info related to recall of medical devices, corrections and removals; regulations and Federal Register notices.
If you cannot trace any real health risks to the missing label, then you may be able to justify why you don't need to do a recall. But you need to make sure you are following your own procedures and documenting appropriately.
It's best to run through a thought experiment/scenario where your device is involved in an incident and see how it plays out. Maybe your device is just one of four devices involved in a serious incident and based on initial reports your company is pretty confident it's not the cause.
But the authorities see the missing NRTL mark as a red flag and start to dig deeper and unearth other problems in production control or design.
It might seem unfair, but the missing NRTL mark is evidence of poor quality control at some level, so it is a valid red flag despite not being a safety issue directly. Statistically it suggests similar quality control problem could exist elsewhere. Or to put it in a less scientific way, if you can't get the labelling right, what else lurks below? So while a company is thinking "it's not a safety issue" the regulators might see it in a somewhat different light.
Of course, if you are 110% confident that your broader regulatory controls can stand up to a deep regulatory probe, then sure, go with the "not a safety issue" route.
But the authorities see the missing NRTL mark as a red flag and start to dig deeper and unearth other problems in production control or design.
It might seem unfair, but the missing NRTL mark is evidence of poor quality control at some level, so it is a valid red flag despite not being a safety issue directly. Statistically it suggests similar quality control problem could exist elsewhere. Or to put it in a less scientific way, if you can't get the labelling right, what else lurks below? So while a company is thinking "it's not a safety issue" the regulators might see it in a somewhat different light.
Of course, if you are 110% confident that your broader regulatory controls can stand up to a deep regulatory probe, then sure, go with the "not a safety issue" route.
CharlieUK
Quite Involved in Discussions
I'll add another question / thought: How was the operator able to use a draft label file?
Product labelling is a key part of product compliance - similar to comments above "if you know you got the label wrong, are you sure you didn't get anything else wrong?"
Product labelling is a key part of product compliance - similar to comments above "if you know you got the label wrong, are you sure you didn't get anything else wrong?"
Label mistakes could rise to the level of 'adulterated product' with the regulators. A NRTL isn't likely to care about products their symbol doesn't appear on... up until the point at which the manufacturer begins stammering something like "the NRTL's mark was supposed to appear on those products."
I'd also point out that my understanding is that a Recall (of all types in the US) is only required where you have broken the law ("A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA)"). You can conduct a field action that is not a Recall.
When we had to re-label some product in the past (can't remember why), our NRTL required that we "verify" the application of the label - thye trust us to put the label on in our production facility, but they were talking about having to sent NRTL staff t owatch us fix the label, so keep an eye out for that.
When we had to re-label some product in the past (can't remember why), our NRTL required that we "verify" the application of the label - thye trust us to put the label on in our production facility, but they were talking about having to sent NRTL staff t owatch us fix the label, so keep an eye out for that.
Agreed. The missing logo points to a bigger issue in how we label stuff in production. This will be what we discover as we go through the CAPA. We will need to fix our processes so this does not happen again. That's the corrective action part. My concern is with the immediate correction...does that even need to be done as it's just an NRTL logo that was not applied when it should have been.
