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).
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Lee Leichter RAC
President
Fort Myers FL
United States
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Original Message:
Sent: 19-Jun-2018 11:18
From: Dan O'Leary
Subject: Ineffective Recall
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.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 17-Jun-2018 21:08
From: Anonymous Member
Subject: Ineffective Recall
This message was posted by a user wishing to remain anonymous
Hi,
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?
Thanks