What is a mock recall?

A mock recall is when you practice a recall internally or with the help of a distributor. You are not actually performing the recall. You notify your distributor or someone on your team of what lot you want to practice with. Then that person has to determine how many units were shipped, how many remain in inventory, where the units were shipped, and they need to provide all of the contact information for each recipient. This also needs to be done quickly with 100% accuracy.
Everyone has anxiety when it is necessary to conduct recalls, advisory notices, field corrective actions and removals of medical devices. The solution is to practice before you need to execute for real.
There are four, basic elements needed:
1. a detailed work instruction that anyone can follow without prior instructions
2. a template for the type of recall
3. a computerized database of all distribution
4. a method of generating labels for envelopes quickly and accurately (i.e., mail merge)
If you are doing this outside of your organization, you should have a supplier agreement that specifies that this will be done as part of supplier re-evaluation.
If you are doing this in-house, you should have this as part of your documented training requirements for competency verification.
Make sure that everyone understands this is a practice or "mock recall" and not real.
You should keep records of successful completion. If mistakes are made, then you need to identify the root cause. implement corrective actions, and repeat the exercise.
If you have less than 10 shipments, you could probably justify not using computerized methods but do not try to do this manually for dozens of shipments. You will make a mistake.
You should also make sure that you are doing this for each country that is applicable.

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[@MedicalDeviceAcademy]

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