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1. PURPOSE
The purpose of this procedure is to define [Company Name]’s requirements for recalls and advisory of medical
devices.
2. SCOPE
This procedure applies to medical devices distributed in the United States, Canada and the European Union.
This procedure is the primary document meeting the applicable regulatory requirements for recalls and advisory
notices as defined in [Company Name]’s Quality System Manual (POL-001).
3. REFERENCES AND RELATIONSHIPS





21 CFR 7 – FDA Enforcement Policy
21 CFR 806 – FDA Corrections and Removals
MEDDEV 2.12/1 – Guidelines on Medical Devices Vigilance System
o Field Safety Corrective Action (FSCA)
o Field Safety Notice (FSN) Template
SOR 98/282, Sections 63-65 – Recalls
Health Canada Guidance to Recall of Medical Devices (GUI-0054)
SYS-024 CAPA Procedure
SYS-020 Recalls and
Advisory Notices
SYS-023 Non-Conforming
Product Procedure
4. DEFINITIONS
4.1 Bounding – is the scope of product codes, lots or serial numbers that may be subject to recall or an
advisory notice. If a specific cause is identified, such as an equipment failure on a specific date then
the bounding should be specific to the cause. If the specific cause is not identified during an
investigation, then statistical techniques should be utilized to identify the depth of the corr ective
actions.
4.2 Consignee – any person or firm that has received, purchased, or used a device s ubject to correction
or removal (see 21 CFR 806c).
4.3 Correction – the repair, modification, adjustment, relabeling, destruction, or inspection (including
patient monitoring) of a device without its physical removal from its point of use to some other
location (see 21 CFR 806d).
4.4 Correction or Removal Report Number – the number that uniquely identifies each report submitted
(see 21 CFR 806e).
4.5 Field Safety Corrective Action – An action taken by a manufacturer to reduce a risk of death or
serious deterioration in the state of health associated with the use of a medical device that is already
placed on the market. Such actions, whether associated with direct or indirect h arm, should be
reported and should be notified via a Field Safety Notice (see MEDDEV 2.12/1).
4.6 Field Safety Notice (FSN) – A communication to customers and/or users sent out by a manufacturer
or its representative in relation to a Field Safety Corrective Ac tion (see MEDDEEV 2.12/1).
4.7 Market Withdrawal – a correction or removal of a distributed device that involves a minor violation
of the act that would not be subject to legal action by FDA or that involves no violation of the act,
e.g., normal stock rotation practices (see 21 CFR 806i).
4.8 Mock Recall – An exercise conducted with [Company Name]’s customer service or a distributor in
order to assess the adequacy of quality system processes required to conduct a recall. The exercise
involves sending a letter announcing a “Mock Recall” of a specific lot or lots of product. Customer
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service or a distributor must provide distribution records in a timely manner related to the lot or lots
subject to the Mock Recall.
4.9 Removal means the physical removal of a device from its point of use to some other location for
repair, modification, adjustment, relabeling, destruction, or inspection (see 21 CFR 806j).
4.10 Risk to Health (see 21 CFR 806k):
4.10.1 A reasonable probability that use of, or exposure to, the product will cause serious adv erse
health consequences or death; or
4.10.2 That use of, or exposure to, the product may cause temporary or medically reversible
adverse health consequences, or an outcome where the probability of serious adverse health
consequences is remote.
4.11 Routine Servicing – any regularly scheduled maintenance of a device, including the replacement of
parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and
responses to normal wear and tear. Repairs of an unexpected nature, replaceme nt of parts earlier
than their normal life expectancy, or identical repairs or replacements of multiple units of a device
are not routine servicing (see 21 CFR 806l).
4.12 Stock Recovery – the correction or removal of a device that has not been marketed or that has not
left the direct control of the manufacturer, i.e., the device is located on the premises owned, or
under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit
involved in the corrective or removal action has been released for sale or use (see 21 CFR 806m).
4.13 Unique Device Identifier (UDI) – an identifier that adequately identifies a device through its
distribution and use by meeting the requirements of 830.20 of this chapter. A UDI is composed of a
Device Identifier (DI) and a Production Identifier (PI) (see 21 CFR 806n).
5. DOCUMENT APPROVAL
Changes to this procedure document and associated forms and templates are to be approved by the Quality
Management.
REVISION HISTORY
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What changed?
Why did it change?
Author
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Establishing new Quality System
R. Packard
6. RESPONSIBILITIES AND AUTHORITIES
Role
Responsibilities and Authorities
Quality Management /
Management Representative
Primary responsibility for maintaining this process and executing recalls and
advisory notices.
Product Development
Product Development is responsible for supporting investigations of device
malfunctions to determine the root cause of a malfunction and to assist in the
evaluation of the need to for corrective actions—including advisory notices and
recalls. Product Development representatives responsible for these activities
should understand the procedure and have documented training prior to
becoming involved in potential recalls or advisory notices.
Customer Service
Management responsible for sales / distribution records is responsible for
communicating recalls and advisory notices to customers. This group may also
be required to assist with the bounding of lots of product that are subject to a
recall or advisory notice.
Executive Management
Quality management, product development, customer service and executive
management together are responsible for initiating a recall/advisory notice and
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Responsibilities and Authorities
coordinating related activities. In an emergency, and when there is no time to
assemble all functions responsible for a recall/advisory notice, executive
management is authorized to initiate a recall/advisory notice. Not all executive
management may be responsible for this activity, but at least one person must be
identified as a back-up to Quality Management / Management Representative.
7. PROCEDURE
7.1 General
1
2
Quality management and/or the complaint handling unit assign the responsibility for evaluation of the
need for corrective actions in accordance with the CAPA procedures (SYS-024).
Whenever possible a cross-functional team that includes the following should be assembled to evaluate
the need for corrective actions that may require a recall or advisory notice:
3
1. Quality management
2. Product development
3. Customer service
4. Executive management
If a recall or advisory notice is warranted, the following parameters should be determined by the team:
4
1. the extent and nature of health hazard and recall classification;
2. proposed depth of recall (i.e., bounding of lots);
3. type of notice to consignees (i.e., e-mail, letter, fax or telephone);
4. content of notice to consignees; and
5. method for verifying effectiveness of a recall.
A recall does not include a market withdrawal or stock recovery.
5
Mock recalls are recommended as a method of verifying effectiveness of quality system processes
required to execute a recall—including adequacy of distribution records. Mock recalls are not reported
to regulatory agencies.
7.2 United States
1
Documentation of recalls and advisory notices must conform with the requirements of 21 CFR 806.10:
1.
2.
3.
4.
5.
A report recall report number that consists of [Company Name]’s 7-digit registration number;
followed by the month, date and year the recall was initiated (e.g., 6-28-15); followed by a
character designating if the recall report is for a correction “-C” or removal “-R”; and finally a
three-digit sequencing number (i.e., -002 for the second report submitted by [Company Name] on
the same day).
The name, address, and telephone number of [Company Name], and the name, title, address, and
telephone number of [Company Name]’s representative (i.e., the management representative)
responsible for conducting the device correction or removal.
The brand name and the common name, classification name, or usual name of the device and the
intended use of the device.
Marketing status of the device (i.e., any applicable premarket notification number, premarket
approval number, or indication that the device is a preamendments device) and the device listing
number. [Company Name] shall indicate in the report whether it has ever registered with FDA if it
does not currently have an FDA establishment registration number.
If the device has a Unique Device Identifier (UDI), the UDI that appears on the device label or on
the device package. If there is no UDI, the device identifier, universal product code (UPC), model,
catalogue, or code number of the device and the manufacturing lot or serial number of the device or
other identification number.
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6.
2
3
3
4
The company name, address, telephone number and contact person if different from that of the
person submitting the report.
7. A description of the event(s) giving rise to the information reported and the corrective or removal
actions that have been, and are expected to be taken.
8. Any illness or injuries that have occurred with use of the device. If applicable, include the Medical
Device Report (MDR) numbers.
9. The total number of devices manufactured or distributed subject to the correction or removal and
the number in the same batch, lot, or equivalent unit of production subject to the correction or
removal.
10. The date of manufacture or distribution and the device's expiration date or expected life.
11. The names, addresses, and telephone numbers of all domestic and foreign consignees of the device
and the dates and number of devices distributed to each such consignee.
12. A copy of all communications regarding the correction or removal and the names and addresses of
all recipients of the communications not provided in accordance with item #11 above.
13. If any required information is not immediately available, a statement as to why it is not available
and when it will be submitted.
[Company Name] is responsible for determining if a recall shall be reported to the District Office of the US
FDA Office of Regulatory Affairs (ORA). If [Company Name] determines that reporting is required, the
recall shall be reported within 10 working days of initiating the recall.
The need to report a recall depends upon the risk to users and/or patients. Documentation of risk shall be in
the form of a Health Hazard Evaluation (HHE). The following webpage provides a sample form of an HHE:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm126206.
htm
[Company Name] should also determine the likely classification of recall (i.e., Class I, II or III) in accordance
with 21 CFR 7.3. However, the district office of ORA may disagree with [Company Name]’s classification.
If [Company Name] determines that reporting of a recall to the ORA district office is not required, this
determination must be documented in accordance with 21 CFR 806.20. Other countries, such as Health
Canada, require reporting of recalls and advisory notices in all instances.
The following webpage should be used for identifying the correct district office within ORA for recalls and
advisory notices:
http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm
In the case of recalls conducted by foreign manufacturers, or if [Company Name] is coordinating a recall in
multiple districts, then ORA Headquarters in Maryland should be contacted.
The ORA recall coordinator should always be contacted to confirm that a recall should be reported—even if
[Company Name] determines that a recalls does not require reporting.
5
If, after submitting a recall report to the ORA district office, [Company Name] or an importer determines
that the same correction or removal should be extended to additional lots or batches of the same device,
[Company Name] initiate an extension of the correction or removal and amend the report within 10-working
days of initiating the extension. The report of the extension shall cite the original report number assigned.
6
[Company Name] is required to submit a periodic status report(s) to the district office of ORA. The
reporting interval will generally be every 2-4 weeks. A periodic status report should include the following
information:
1.
2.
3.
4.
5.
6.
Number of consignees notified of the recall, and date and method of notification.
Number of consignees responding to the recall communication and quantity of products on hand at
the time it was received.
Number of consignees that did not respond (if needed, the identity of non-responding consignees
may be requested by the district office of ORA).
Number of products returned or corrected by each consignee contacted and the quantity of products
accounted for.
Number and results of effectiveness checks that were made.
Estimated time frames for completion of the recall.
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Periodic recall status reports are to be discontinued when the recall is terminated by the district office of
ORA.
7.3 Canada
1
The [Company Name] and the importer of a medical device shall, on or before undertaking a recall of the
device, each provide the Minister with the following:
1.
2
3
4
5
the name of the device and its identifier, including the identifier of any medical device that is part
of a system, test kit, medical device group, medical device family or medical device group family;
2. the name and address of the manufacturer and importer, and the name and address of the
establishment where the device was manufactured, if different from that of the manufacturer;
3. the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on
and circumstances under which the defectiveness or possible defectiveness was discovered;
4. an evaluation of the risk associated with the defectiveness or possible defectiveness;
5. the number of affected units of the device that the manufacturer or importer manufactured in
Canada, imported into Canada, and sold in Canada;
6. the period during which the affected units of the device were distributed in Canada by the
manufacturer or importer;
7. the name of each person to whom the affected device was sold by the manufacturer or importer and
the number of units of the device sold to each person;
8. a copy of any communication issued with respect to the recall;
9. the proposed strategy for conducting the recall, including the date for beginning the recall,
10. information as to how and when the Minister will be informed of the progress of the recall and the
proposed date for its completion;
11. the proposed action to prevent a recurrence of the problem; and
12. the name, title and telephone number of the representative of the manufacturer or importer to
contact for any information concerning the recall.
No justification of not informing Health Canada can be provided. Health Canada should always be informed
of a recall in Canada.
The US FDA and Competent Authorities in Europe may also require notification of a recall in Canada if the
same devices are distributed in the USA or the European Union.
The following contact information should be used for notifying Health Canada of recalls:
Medical Devices Compliance Unit
Health Products and Food Branch Inspectorate
Health Canada
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
Canada
Telephone: +1.613.954.6666
Fax: +1.613.954.0941
MDCU_UCIM@hc-sc.gc.ca
[Company Name] and the importer of a medical device shall, as soon as possible after the completion of a
recall, each report to the Minister
a) the results of the recall; and
b) the action taken to prevent a recurrence of the problem.
6
[Company Name] should consult the “Guidance to Recall of Medical Devices (GUI-0054)” for further
information regarding recalls in Canada. This guide can be found on the following webpage:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui-0054_recall-retrait-doc-eng.php
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7.3 Europe
1
2
3
4
5
A Field Safety Corrective Action (FSCA) is initiated by [Company Name] to reduce the risk of death or
serious deterioration in the state of health associated with the use of a medical device that is currently
distributed in the EU.
Whether the device could directly or indirectly cause harm, the FSCA shall be reported to the National
Competent Authority for all countries affected at the same time.
The US FDA and Health Canada may also require notification of a recall in the European Union if the same
devices are distributed in the USA or Canada.
The required content for a FSCA or an FSN is defined in MEDDEV 2.12/1.
The most current version of MEDDEV 2.12/1 and the associated forms can be found at the following
webpage:
http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.


6
Use the template in Annex 4 for a FSCA
Use the template in Annex 5 for a FSN
The contact information for the National Competent Authority in the country of occurrence can be found at
the following webpage:
http://ec.europa.eu/health/medical-devices/links/contact_points_en.htm.
7
A draft of a FSCA or a FSN should be provided to the National Competent Authority where the Authorized
Representative is located, and [Company Name] should allow a minimum of 48 hours for receipt and
comment prior to initiation—unless the nature of the FSCA dictates a shorter timescale (e.g., for a Serious
Public Health Threat).
7
[Company Name]’s Authorized Representative Agreement includes a requirement for all Field Safety
Corrective Actions and Field Safety Notices to also be sent to the Authorized Representative. The
Authorized Representative should also be used as a resource during the decision making process when
[Company Name] is determining if notification of Competent Authorities is required.
8
[Company Name]’s Notified Body Contract requires that copies of all Field Safety Corrective Actions and
Field Safety Notices also be sent to the Notified Body.
8. MONITORING AND MEASUREMENT
Internal auditing should include verification of compliance with national and international requirements for recalls
and advisory notices during the review of the complaint handling process (i.e., ISO 13845, Clause 8.5.1) and the
CAPA process (i.e., ISO 13485, Clause 8.5.2) to ensure that this procedure is being followed. If the decision to
conduct and/or report recalls and advisory notices is not being done correctly, additional training should be provided
along with specific examples of errors.
9. TRAINING/RETRAINING
Role
Training or Retraining Required
Quality Management /
Management Representative
Shall be trained and be competent in all aspects of this procedure.
Executive Management
Shall be trained and be competent in all aspects of this procedure. Not all
Executive Management may be responsible for this activity but at least one
person must be identified as a back-up.
10. RISK MANAGEMENT
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Hazard
Risk control measures
1.
Adulterated or misbranded product is
not recalled.
Training on 21 CFR 807, 21 CFR 806, European requirements
and Canadian Medical Devices Regulations.
2.
Not all product that requires corrective
action is corrected or removed.
Use of statistical techniques (see SYS-022, Statistical
Techniques) for bounding of applicable lots of product unless
specific cause is known.
11. RECORDS
Records associated with this process are the subject of the following related procedures:
1.
2.
SYS-004, Training & Competency
SYS-002, Record and Data Control