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  • 1.  Ineffective Recall

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jun-2018 09:15
    This message was posted by a user wishing to remain anonymous


    For a recall carried out in the past , which has been closed by the regulators but if today , we get complaints of the same nature showing our recall effectiveness checks were not carried out properly; how should this be handled now?


  • 2.  RE: Ineffective Recall

    Posted 18-Jun-2018 10:14
    You may have to open a CAPA and depending upon the outcome, may have to initiate another recall. Is it possible that there was not a response from the user/patient even after the 'x' number of attempts to notify as specified in your recall procedures? If yes, that can be used as rationale for terminating the previous recall. But if there are defective products out there that need to be removed, I don't see any other route than a health risk determination and possible removal.

    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States

  • 3.  RE: Ineffective Recall

    Posted 19-Jun-2018 07:37
    Hello there,

    I agree with Vidyalakshmi. 

    Also,  recall effectiveness checks are checks on the effectiveness of the conduct of recall activities themselves. That  really is separate from determining the correct root cause during complaint/non-conformance investigation. It sounds as if you had an ineffective investigation for that, or there was another cause you did not suspect,  leading to that failure.

    Yes, a thorough investigation into complaint with a new or reopened CAPA is in order I think. If this is a device, revisit your risk management file as well, it might need updating.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC
    (715) 307-1850

  • 4.  RE: Ineffective Recall

    Posted 19-Jun-2018 11:19

    In my opinion you need to distinguish between the recall strategy and the recall's ability to recover all products. Under the assumption that the recall is a removal, you could have had an acceptable recall strategy without 100% removal.

    Following the Device Advice on the FDA website, a recall has two important characteristics for this purpose: depth of recall and effectiveness check.

    The depth of recall defines who is informed: user level, retail level, or wholesale level. Each level includes the one above it.

    The effectiveness check has five levels and defines the percentage of consignees who received notification about the recall and have taken appropriate action.

    For example, you could have a recall strategy that contacts 75% (Level B) of the consignees at the wholesale level. This recall strategy would not ensure that 100% of the product is removed. Therefore, you could easily continue to receive complaints; you need to address each one individually.

    There is, in my opinion, only one case where a complaint that identifies a recalled product should lead to a concern about the recall. That is when the depth of recall is at the user level and the effectiveness check is 100% (Level A). This combination is the only one that assures 100% removal because you contact everybody who has the device and they all take action.

    If FDA closed the recall, that indicates you successfully implemented the recall strategy. Unless the strategy was User-Level A, there is no reason to assume a nonconformity in the recall and no reason for corrective action.

    You didn't say which geographic region was involved, so I inferred FDA. You could apply the same analysis outside the US.

    Dan O'Leary
    Swanzey NH
    United States

  • 5.  RE: Ineffective Recall

    Posted 20-Jun-2018 07:56
    ​I agree wholeheartedly with Dan, who always seems to give very well reasoned and sound advice.  I disagree with other responses to this post.  If this is an identified problem on lots that have been identified with, and recalled for this problem, then documenting this in each individual complaint file is the appropriate action. I would also suggest following up with the complainant to inform them that these were recalled and request any additional affected device be returned  Do NOT open a CAPA. Do NOT open or extend the closed recall.

    The only exception to this would be if the problem occurs outside of the recalled lots.

    As Dan has said, most, if not all recall are NOT 100% effective and there is always the expectation that you will continue to receive complaints (hopefully in a diminishing number over time) as the devices are consumed or reach expiration (if sterile).

    Lee Leichter RAC
    Fort Myers FL
    United States

  • 6.  RE: Ineffective Recall

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jun-2018 09:15
    This message was posted by a user wishing to remain anonymous

    ​If the lot was not identified for the recall, then it means opening  a new CAPA or reopening the old one ? verify no other lots are missed ?Then proceed in the same way as for other recalls ?

  • 7.  RE: Ineffective Recall

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2018 11:22
    This message was posted by a user wishing to remain anonymous

    ​The recall involved a correction , notified at the user level and to the service tech;if the customer actions were satisfactory , the correction was to happen at the next service visit, which probably was not satisfactory or did not happen. This was a worldwide correction but the report now is from outside US. Does this mean we have to investigate all the corrections that  have been done regarding this complaint and would this again require reporting to all the agencies ?