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What is Recall?

A recall is an action taken to address a problem with a medical device.  Recall occurs when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.    In other words, a recall is initiated when a medical device :
          -  is or may be hazardous to health
          -  fails or may fail to conform with any calims made by the manufacturer relating to the effectiveness, benefits, performance characteristics or safety of the device
          -  does not comply with the regulatory requirements.

A medical device recall does always mean that you must stop using the product or return it to the manufacturer/supplier.  A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.  If an implanted device e.g. a pacemaker or an artificial hip, it does not always have to be removed.  When an implanted device has the potential to fail unexpectedly, manufacturers often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

Examples of the types of actions that may be considered recalls :
          -   inspecting the device for problems
          -   repairing the device
          -   adjusting settings on the device
          -   re-labeling the device
          -   destroying the device
          -   notifying patients of a problem
          -   monitoring patients for health issues

Sometimes a company may have concerns about a group of products, but it cannot predict which individual devices will be affected.  To be on the safe side, the company may recall an entire lot, model, or product line.

A recall is either a correction or a removal depending on where the action takes place :
          Correction  -  addresses a problem with a medical device in the place where it is used or sold.
          Removal     -  addresses a problem with a medical device by removing it from where it is used or sold.

Who recalls medical devices?

In most cases, a company (manufacturer, distributor, or other authorised party) recalls a medical device voluntarily.  When a company learns that it has a product that has a problem, it :
          1.  recalls the device (through correction or removal); and
          2.  notifies the MDB.
MDB, however, can require a company to recall a product.  This could happen if a company refuses to recall a device that is associated with significant health problems or death.

What happens in a medical device recall?

When a company recalls a medical device, it
     -  contacts directly the customers who received the product from them, and takes actions to reach others who need to be notified (e.g. by issuing press releases or providing detailed instructions);
     -  supplies information to help users identify the product and take actions to minimise health consequences; and
     -  takes action to prevent the problem from happening again.

MDB will oversee each recall to make sure that the actions the company takes are adequate to protect the public health.  During a medical device recall, MDB :
     -  works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again;
     -  conducts audits to make sure the recall efforts are appropriate and effective;
     -  makes sure the company takes necessary actions to prevent the problem from happening again.

MDB classifies medical device recalls into three categories, reflecting the potential risk to public health:
             Class I     -   High risk
             Class II    -   Less serious risk
             Class III   -   Low risk

This classification process usually takes place after the company has issued its recall.  MDB's classification determines the number of checks the company has to make and the number of audits MDB will conduct to ensure the effectiveness of the recall action.  It is intended to make sure the company has followed on its decision to implement the recall action.

The responsibility for an adequate recall belongs to the manufacturer.  The decision and timing of MDB's recall classification does not change or delay the company's obligation to take appropriate action.

What is a Class I Recall?

A Class I recall is the most serious type of recall.  In a class I recall, there is a reasonable chance that the product will cause serious health problems, injury or death.
Examples of Class I recall :
          -  wrong products (label and contents are different products)
          -  microbial contamination of sterile injectable or ophthalmic product
          -  chemical contamination with serious medical consequences
          -  mix up of some products with more than one container involved
          -  wrong active ingredient in a combination product with serious medical consequences
In such a recall, the company :
    -  notifies their customers (i.e. distributors) and directs them to notify the intended recipients of the device (i.e. other distributors, hospitals, other healthcare facilities, doctors or individual patients).  The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reasons for the recall, and instructions about how to correct, avoid, or minimise the problem.  It should also provide a telephone number for questions related to the recall.
   -  issues a press release to notify the public, if appropriate, to minimise health consequences>

MDB may also issue its own press release or public health notice.  MDB will also posts consumer information through its website.

What is Class II Recall?

A Class II recall usually represents a less serious risk than a Class I recall.  In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is remote chance that the device will cause serious problems.
Examples of Class II recall :
     -  mislabeling e.g. wrong or missing text or figures
     -  missing or incorrect information - leaflets or inserts
     -  microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences
     -  chemical / physical contamination (significant impurities, cross contamination, particulates)
     -  mix up products in containers
     -  non-compliance with specification
     -  insecure closure with serious medical consequences
In a Class II recall, the company notifies their customers (i.e. distributors) and sometimes asks them to notify the intended recipients of the device.  MDB does not issue a press release or expect the company to issue a press release for Class II recalls, unless there is a specific need to do so (e.g. if the device could affect the health of a large number of people, if patients need more information, or if the recalling company could not reach every intended recipient).

What is Class III Recall?

A Class III recall represents a less serious risk than a Class II recall.  In a Class III recall, there is little chance that using or being exposed to the device will cause health problems.  However, because the product is having problem, there is still a need to take an action to address the problem.
Examples of Class III recall :
     -  faulty packaging e.g. wrong or missing batch number or expiry date
     -  faulty closure
     -  contamination - microbial spoilage, dirt or detritus, particulate matter
In a Class III recall, the company notifies their customers (i.e. distributors).  MDB would not issue a press release, and it would not expect the company to issue a press release.

Note  :   Class I or Class II recalls are considered to be urgent safety-related recalls, while Class III recalls are considered to be routine non safety-related recalls.
Each recall is a unique exercise and there may be occasions when the scope of a recall can be narrowed to particular customer groups.  The classification is determined by consultation between the manufacturer (or marketing authorisation holder) and the MDB.  Expert advice may be sought where the nature of the hazard or its significance is not clear.
The level or depth of a recall is to be determined by consultation between the manufacturer (or marketing authorisation holder) and the MDB.  In determining the recall level, the principals factors to be considered are the significance of the hazard, if any, the channels by which the goods have been distributed, and the level to which distribution has taken place.  Again expert opinion may be necessary to determine the significance of teh hazard.  (There are a number of levels of recalls : wholesaler, hospital, clinic, retailer, and consumer).

Advertisement

If the depth of a recall is to consumer or retail level and teh consumers or retail outlets cannot be identified, advertisements paid by the manufacturer (or the marketing authorisation holder) are to be inserted in the daily print media.

Every notice of recall to the public through the media must include :
         1.  name of product
         2.  registration number
         3.  unique identifying number, if any
         4.  pack size
         5.  model and model number
         6.  batch or serial number
         7.  expiry date (when this appears on the product)
         8.  other details necessary to allow absolute identification (e.g. catalogue / part / order number as appropriate)
         9.  reason to recall
        10. necessity to identify and quarantine the product from further sale or supply
        11. the method of recovery (or disposal, if appropriate) or product correction which will be used
        12. contact number and personnel in-charge

The implementation 

   1.  the establishment / manufacturer has the prime reponsibility for implementing recall action, and for ensuring compliance with the recall procedure at its various stages.
   2.  no recall, regardless of level, should be undertaken without consultation with the MDB and without agreement on the recall strategy.
   3.  in cases of significant hazard to the users, the manufacturer's personnels may be utilised to immediately disseminate information on the recall.
   4.  it is the establishment / manufacturer responsibility to recover product which is subject to recall, providing the provisions and any applicable regulations are observed.
   5.  if the recall involves a local manufacturer that possesses overseas market, the establishment / manufacturer is required to notify overseas recipients of recall actions that affect them.

Post Recall

After the implementation of recall (2 to 6 weeks, or at agreed time frames), the manufacturer (or the marketing authorisation holder) is to provide the MDB with an interim and final reports on the recall.  These reports establish the effectiveness of the recall and form the basis of reports to committee on product safety.  Unless satisfactory reports are received, further recall action may have to be considered.  The reports are to contain the following information :
    a.  the circumstances leading to the recall
    b.  the consequent action taken by the company
    c.  the extent of distribution of the relevant batch in the country and overseas (if applicable)
    d.  the result of the recall - quantity of stock returned, corrected, outstanding, etc
    e.  confirmation, where practicable (e.g. hospitals, clinics) that customers have received the recall letter / notice
    f.  the method of destruction or disposal of recalled goods
    g.  the action peoposed to be implemented in future to prevent a recurrence of the problem.

Any queries please contact :

If you are a patient, healthcare professional, or work for medical device manufacturer and would like more information on the work of MDB, or if you like to know how you can contribute to the safe use of medical device, please contact us at :

                            Chief Executive,
                            Medical Device Authority (MDA), Ministry of Health Malaysia,
                            Level 5, No. 26, Menara Prisma, Precinct 3,
                            62675 Putrajaya, MALAYSIA.
                            Tel: +603-8892 2400 | Fax : +603-8892 2500

                            E-mail :   This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

                            Contact Person: Mr Mohd Zulhisham 

Last Updated ( Thursday, 12 September 2013 )
 
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