Recalls & Field Safety Corrective Actions

CDRRHR · DOH AO 2015-0001 · 24-hour notification · PH-Unique BoC coordination

When a Recall or FSCA Is Required

A Field Safety Corrective Action (FSCA) is required when a marketed device presents a risk to patient safety that was not previously identified or has become newly significant. Triggers include:

• A defect identified in the device design, materials, manufacturing, or labelling
• A pattern of adverse events pointing to a systemic device issue
• An FSCA initiated in another market for the same device
• A CDRRHR-directed recall based on post-market surveillance findings

24-Hour Notification Rule — PH-Unique

Upon becoming aware of a defect or safety issue requiring corrective action, the license holder must notify CDRRHR within 24 hours. This is a strict Philippines requirement — do not delay notification while investigating the full scope.

The 24-hour notification is a preliminary notification — a complete FSCA plan with supporting documentation may follow, but the initial alert to CDRRHR must be immediate.

FSCA Process

1. 24-hour notification to CDRRHR — provide initial description of the issue and affected devices
2. FSCA plan preparation — identify affected lots, distribution scope, corrective action type
3. Field Safety Notice (FSN) preparation — clear, factual notice for users and distributors
4. Simultaneous or prior notification to CDRRHR before notifying users — do not send FSN to users without CDRRHR awareness
5. Distribution of FSN — to all known users, distributors, and healthcare facilities with affected devices
6. Execution of corrective action — recall, repair, relabelling, or user notification as appropriate
7. Bureau of Customs coordination — notify CDRRHR to coordinate BoC interception of imported shipments not yet delivered (see below)
8. Final report to CDRRHR — reconciliation of affected units, outcomes, and CAPA

Types of Corrective Action

FSCA Type	Description
Recall	Physical return of affected devices to the manufacturer or distributor
Market withdrawal	Removal from sale without return (non-safety-related defect)
Modification / repair	On-site correction of devices in the field
Relabelling	Correction of safety-critical labelling error
User notification	Safety advisory without physical device action

Recall Classification — PH Framework

CDRRHR classifies recalls based on the severity of the risk:

Class	Risk Level	Description
Class I	High	Reasonable probability of serious adverse health consequence or death
Class II	Moderate	May cause adverse health consequence; probability of serious harm is remote
Class III	Low	Unlikely to cause adverse health consequence; administrative or labelling issues

CDRRHR determines the recall class. The class affects communication urgency, timeframe for completion, and reporting requirements.

Bureau of Customs Coordination — PH-Unique

When an FSCA requires stopping importation of affected devices not yet cleared customs:

• Notify CDRRHR immediately of the lot numbers and shipment details
• CDRRHR coordinates with the Bureau of Customs (BoC) to intercept and hold affected shipments
• Do not assume automatic interception — proactive notification to CDRRHR is required

This mechanism is unique to Philippines and requires the license holder to maintain accurate import shipment tracking to provide BoC-usable information (lot numbers, shipment dates, BoC reference numbers).

Distribution Records — Essential for Recall Execution

Effective recall execution depends on being able to identify and contact all recipients of affected devices. License holders must maintain distribution records sufficient to trace each device or lot to the point of delivery. See Post-Market Overview for distribution record requirements.

CDRRHR-Initiated Recalls

CDRRHR may order a mandatory recall if:

• The license holder fails to initiate a voluntary recall when required
• The device poses an imminent public health risk
• Post-market surveillance data indicates a serious safety concern

Failure to comply with a CDRRHR recall order is a violation of RA 9711 and may result in LTO revocation and criminal prosecution.

Record-Keeping

Maintain the following for each FSCA:

• 24-hour notification record (with timestamp)
• FSCA plan and Field Safety Notice
• Distribution list of recipients contacted
• Acknowledgement records from customers
• Reconciliation of affected units returned or otherwise dispositioned
• Final CDRRHR closure report

Records must be retained for the duration of the device's expected lifetime plus a reasonable period, or as directed by CDRRHR.