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  • 1.  Recall notice acknowledgements

    This message was posted by a user wishing to remain anonymous
    Posted 17-Jun-2021 11:38
    This message was posted by a user wishing to remain anonymous

    In these days of covid, it is very difficult to get hospitals to acknowledge receipt of a recall notice.  In those cases where there is no other corrective action, how do you get the hospitals to respond?  I've heard of companies using 3rd parties for this or offering incentives.  How does this work?  If the hospital does not respond after repeated attempts, what is best practice for closing the recall?  I've heard FDA requires three documented attempts.

  • 2.  RE: Recall notice acknowledgements

    Posted 18-Jun-2021 08:52
    Good Day,

    Our FDA inspector advised us to show "due diligence" for those who do not respond.  When I asked him/her how much that was, they said, 3-5 thoroughly documented attempts.  We also send a recall notice certified mail, return receipt depending on the seriousness of the recall.  I will qualify this by saying we have not had a recall in over 20 years though.

    Best regards,

    D Michelle Williams
    VP - Operations
    United States

  • 3.  RE: Recall notice acknowledgements

    Posted 18-Jun-2021 12:41

    We are hard pressed to find a definitive official statement from the FDA about the number of attempts required to achieve a sufficient amount of follow-up regarding a recall notification.  I've seen FDA assert that at least three documented attempts is required.

    The only official FDA position from FDA about the amount of such follow-up of which I'm aware is that FDA has stated that the need for follow-up notification of consignees may vary depending on the specific action (e.g., removal or correction), recall classification, and strategy for that particular recall.  FDA says that instead of having specific and rigid instructions to cover all recall situations, FDA's recall regulations recognize that variations may be appropriate to assure that affected consignees (and in certain cases, specific segments of the affected health care community) receive a communication that will result in prompt and necessary action on their part.

    For a related context (complaint evaluation/investigation), FDA has stated it expects us to make a "good faith" effort.  FDA has stated that a single call to a hospital would not be considered by FDA to be a reasonable, good faith effort to obtain information.

    In terms of the actual methods utilized to get the intended recipients to respond, FDA did a field test of various methods back in the day, and then formulated its regulation and position accordingly.  Specifically, FDA's field test showed that various different methods may be necessary to achieve an appropriate level of response commensurate with the categorization of the recall (i.e., with the seriousness of the problem).  Personal visits, letters, telephone calls, or a combination of these methods may be used.

    Personally, I've had the best results by applying good old fashioned customer service tactics expressing a genuine desire to serve and protect the customer.  Incorporating such signals in the recall communications and related follow-up can mean the difference between a response and silence.  I've even used in person visits to customer sites when the seriousness of the issue warranted.

    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
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