Receipt of a tissue product recall should prompt immediate action.


A facility that handles tissue implants or organ transplants should have:

(1) a policy for dealing with product recalls.

(2) a means of tracking the location and disposition of a product at all times


Actions upon receipt of a recall notice:

(1) Date and time that the notice was received and all actions taken subsequently.

(2) Determine if the recalled product was received at the facility.


If the product has been received:

(3) Determine the product's disposition: in storage, implanted, sent elsewhere.

(4) Create a recall file where all information is placed. This information must be available for at least 10 years and in some cases indefinitely.

(5) Follow the instructions of the recalling facility.

(6) Notify any agencies (FDA, State Health Department, other) as required by law.

(7) If a problem adversely affecting a patient is detected then notify those involved in managing risk (risk management, lawyer, insurance carrier).


Immediate Action

in inventory

quarantine product


notify physician (see below)

shipped elsewhere

notify receiving facility

discarded or destroyed

document how and when


If the physician cannot be notified, then an attempt should be made to reach the patient. If the patient is unable to receive the information then a parent, guardian or family member should be contacted.


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