FSCAs & Recalls
A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer (or MRH in Mexico) to reduce the risk of death or serious injury associated with a medical device already placed on the market. FSCAs include recalls, modifications, exchanges, and advisory notices.
When an FSCA is required
An FSCA should be initiated when:
- A device defect or malfunction could cause or contribute to death or serious injury.
- A safety-related correction is required to bring a device into compliance.
- Clinical or post-market data reveals an unacceptable risk that requires action.
The decision to initiate an FSCA should be driven by your risk management process (ISO 14971). COFEPRIS and CNFV should be notified promptly when an FSCA decision is made.
Types of FSCAs
| FSCA type | Description |
|---|---|
| Recall (retiro) | Physical return of the device to the manufacturer or MRH |
| Safety-related correction | Modification, repair, or software update to devices in the field |
| Safety-related exchange | Replacement of a device with a corrected version |
| User advisory | Hazard notice without product return, for manageable risks |
COFEPRIS/CNFV notification
The MRH must notify CNFV when an FSCA is initiated:
- Notification should include the FSCA rationale, scope, action plan, and timeline.
- COFEPRIS may coordinate with international regulators if the issue affects other markets.
- COFEPRIS may initiate its own mandatory recall action if it deems the risk warrants regulatory intervention.
Field Safety Notice (FSN)
A Field Safety Notice is the written communication sent to customers, distributors, and healthcare facilities when an FSCA is undertaken. The FSN must:
- Clearly identify the affected device (name, model, serial numbers or lot numbers, date of manufacture range).
- Describe the hazard and the action required.
- Provide instructions for the customer (return, stop use, apply correction, etc.).
- Include contact information for the MRH.
- Be drafted in Spanish for the Mexican market.
Record-keeping
All FSCA activities must be documented and included in the Technovigilance Report submitted at registration renewal. Records should include:
- The decision-making process for initiating the FSCA.
- List of affected devices (by serial or lot number).
- Customer contacts and responses.
- Effectiveness checks — confirmation that the FSCA reached all affected customers.