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Version #RP-0001
Recall Process
Purpose
The primary goal of a Medical Devicerecall is to protect public health by removing products that have
been determined to be unsafe for commerce. Our recall plan will aid in the execution of a recall by
distributing duties, centralizing current contact information, and providing prewritten templates for
communications. Key individuals that will be participating in a company recall should review the recall
plan and be familiar with the execution of the plan.
Scope
This document will be used to direct all actions pertaining to Medical Device Recalls at
Definitions
Consignee: Anyone who received purchased or used the product being recalled.
Depth of Recall: Defines the level of product distribution for the recall (consumer, retail, institutional,
wholesale)
Distribution List: A product specific distribution list, which identifies accounts that received the recalled
product. This list should include the name of customer, address, city, province, postal code, and
customer contact, telephone number and email address.
Distribution Records: maintains thorough distribution records of all products sold indefinitely.
Effectiveness Checks: Checks conducted by recalling firm to verify that all consignees have received
notification about the recall and have taken appropriate action.
Recall: In respect of a medical device that has been sold, any action taken by the manufacturer,
importer or distributor of the device to recall or correct the device, or to notify its owners and users of
its defectiveness or potential defectiveness, after becoming aware that the device: a) may be hazardous
to health; b) may fail to conform to any claim made by the manufacturer or importer relating to its
effectiveness, benefits, performance characteristics or safety; or c) may not meet the requirements of
the Act or the Medical Devices Regulations (Section 1 of the Medical Devices Regulations).
Recall Plan: A written contingency plan for use in initiating and implementing a recall in accordance with
Procedure
1.0 - Part 1 – Initiating a Recall
1.1 - Stage One: Identify Need to initiate a recall
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1.2 - Stage Two: Develop Recall strategy and scope
1. Upon receipt of recall notification, immediately schedule a recall committee meeting between
‘Senior Management’: The CEO, EVP Revenue, EVP Supply Chain and Business Operations and
Director of People and Culture.
2. Assess Risk level (Type I, II or III. I being the highest risk) to determine timeline
a. Type I – Immediately initiate recall, notify customers within 3 business days.

b. Type II – Begin process, notify customers within 7 business days.
c. Type III – Notify customers withing 10 business days.
3. Assess parameters
a. Determine which SKUs, and Lots are affected, as per Principal.
b. Determine action to be taken, as per Principal
-Quarantine and cease distribution, Product to be recovered and returned to

Principal
-Quarantine and cease distribution, Product to be disposed of.
-Notification
4. Using the parameters provided, retrieve all distribution records
5. Develop documentation for customers to fill out and return using Acknowledgement Form
(Appendix B)
6. Include any relevant information/documents that were forwarded by the principal.
2.0 - Part 2 – Conducting a recall
2.1 - Stage Three: Notify and correct
1. Notify warehouse managers of recall and to inspect current inventory for affected stock.
a. Warehouse managers will advise Customer Care Manager of any affectedproduct.
i. Send response form along with all quantities and what action was taken
with the product.
b. Proceed based on parameters determined in 1.2.2
2. Once we have distribution records, all customers are notified via Email or Fax within the
timelines provided in section 1.2.1.
3. We require a response from all customers within 2 weeks of the initial recall notification
being sent, whether they have any affectedproduct or not.
4. We log all responses in the distribution records excel file.
5. All returned products will be held in a designated quarantine area in each warehouse.
a. See Appendix B for procedure.
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____________ Date: ___________________
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Version #RP-0001

1.1 - Stage One: Identify Need to initiate a recall

1.2 - Stage Two: Develop Recall strategy and scope

a. Type I – Immediately initiate recall, notify customers within 3 business days.

a. Determine which SKUs, and Lots are affected, as per Principal.

b. Determine action to be taken, as per Principal

-Quarantine and cease distribution, Product to be recovered and returned to

-Quarantine and cease distribution, Product to be disposed of.

4. Using the parameters provided, retrieve all distribution records

6. Include any relevant information/documents that were forwarded by the principal.

2.0 - Part 2 – Conducting a recall

2.1 - Stage Three: Notify and correct

Date: _______

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