# STANDARD OPERATION PROCEDURE -- 6014

**[RECALL PROCEDURE FOR POTENTIALLY HAZARDOUS PRODUCTS]{.underline}**

PURPOSE: To establish a standard operating procedure for the recall of
potentially hazardous commercial products.

POLICY: The facility will track and review the Food and Drug
Administration (FDA) alerts, voluntary manufacturer recalls, VA National
Patient Safety Center, and other regulatory notices received listing
recalls and alerts of externally identified product hazards. . The
Chief, SPD will initiate action to confiscate affected product and
maintain records of action taken according to the facility-established
policy. Hazardous products identified internally will be promptly
reported to the Risk Manager and Safety Officer, or the
facility-designated coordinator.

RESPONSIBILITY: Materiel Manager, SPD Program Manager, SPD Chief, SPD
Supervisors, SPD Staff, Risk Manager, Safety Officer

PROCEDURE:

1.  The FDA has the authority to recall devices which present potential
    risks or substantial harm. When a manufacturer or the FDA recognizes
    that a product is potentially hazardous, action must be taken to
    notify all users of the product and to provide instructions for its
    removal or recall.

2.  The General Services Administration issues "Safety Alerts" on
    potentially hazardous products under its contracts. Other government
    agencies issue notices of hazardous products under their
    jurisdiction.

3.  Manufacturers may also issue warnings or recalls on their products.

4.  The facility Safety Officer, Risk Manager and/or facility designated
    official will be notified, in order to establish the severity of the
    hazard and the action plan to be initiated to limit, restrict, or
    remove the product from use. The Executive Management Team will
    initiate an action plan, remove affected product, track used items,
    and acquire a substitute product.

5.  Once notification of a safety alert or recall is received, the
    Chief, SPD or Program Manager will coordinate the identification and
    retrieval of items being recalled.

6.  The Chief, or the responsible SPD official will advise the
    potentially affected services, instructing them to check their stock
    for the items in question by routing a copy of the hazard recall
    notice to potentially affected services.

7.  SPD staff members will retrieve all the recalled product and
    quarantine the product for disposal or return to vendor.

8.  The Chief, SPD or Program Manager will notify the responsible
    official once all items have been retrieved and/or items that were
    used.

9.  Identified hazards will be reported to the manufacturer, the
    distributor, and the SPD Program Manager in VACO.

10. All recall or hazard notices shall be tracked until all responses
    and corrective actions are received for affected products.

REFERENCES:

JCAHO Accreditation Manual (2002).

Medical Device Amendments of 1992 (Public Law 102-300) FDA Modernization
Act of

1997\.

Safe Medical Device Act of 1990. (Public Law 101-629).

VA Handbook 7125, General Procedures. Part 7 (9/27/2000).

VHA Directive 10-94-010, U.S. Food and Drug Administration Policies.
Retrievable

www.fda.gov