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Recalls and Field Safety Corrective Actions

What is an FSCA?​

A Field Safety Corrective Action (FSCA) is an action taken to reduce a risk of death or serious deterioration of health associated with a medical device already supplied on the market. FSCAs include:

  • Recalls — returning or disposing of devices
  • Field corrections — modifying, adjusting, or reprocessing devices in the field
  • Safety alerts — issuing updated instructions or warnings without physically retrieving the device
  • Restrictions on use — limiting who can use the device or how

An FSCA may be initiated by the manufacturer globally, or by Medsafe in New Zealand specifically.

When is an FSCA required?​

An FSCA is required when:

  • A device defect or failure has caused or could cause serious injury or death
  • A labelling error could lead to misuse resulting in harm
  • An overseas regulator has issued a recall or safety action affecting devices also supplied in NZ
  • Medsafe determines that a device poses an unacceptable risk

Notifying Medsafe​

The Sponsor must notify Medsafe as soon as practicable when an FSCA is planned or underway. Notification should include:

  • Description of the device and the safety issue
  • Scope of the action (how many devices, which customers)
  • The corrective action being taken
  • A draft or copy of the Field Safety Notice (FSN)

Contact Medsafe at devices@health.govt.nz or by phone for urgent situations.

Field Safety Notices (FSNs)​

A Field Safety Notice (FSN) is the communication sent to customers, hospitals, and distributors informing them of the FSCA and what they need to do. An FSN should be:

  • Written in clear, plain language
  • Sent to all affected customers using the Sponsor's distribution records
  • Marked clearly as an "Urgent Medical Device Recall" or "Field Safety Notice" on the envelope/subject line
  • Approved by Medsafe before sending (for significant recalls, Medsafe may review the draft)

Medsafe publishes recall and FSCA information on its website.

Using WAND in a recall​

WAND's key purpose is to enable rapid identification of all sponsors of a device when a safety event occurs. During a recall:

  • Medsafe uses WAND to identify the Sponsor quickly
  • The Sponsor uses their distribution records (not WAND — WAND doesn't have end-customer detail) to identify and contact affected customers
  • The Sponsor should update WAND to reflect the recall status of affected entries

Medsafe-initiated action​

Medsafe has the power under the Medicines Act 1981 to:

  • Direct a Sponsor to take corrective action
  • Issue public safety communications about a device
  • Require a Sponsor to cease supply of a device that poses an unacceptable risk

Post-FSCA reporting​

After completing an FSCA, the Sponsor should provide Medsafe with a close-out report confirming:

  • All affected devices have been accounted for
  • Corrective action has been completed
  • Remaining inventory has been addressed