Catalog Number CLR222US |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Are there any pictures of the box(es) displaying the expiration date?.
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Event Description
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It was reported that the expiration date on the box is showing an expiration date of 2012.There was no patient involvement.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Date sent to fda: 2/2/2018 evaluation of the received sample disclosed that the tyvek label showed an expiration date of 2012-08-31, which is incorrect.Per device history review, the correct expiration date for subject product code (clr222us) and batch (lkh207) combination is 08/16/2019.This is considered as incorrect and/or missing labeling condition.
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Search Alerts/Recalls
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