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).To date, the device has not been returned.If the product is returned for evaluation, 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.
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Event Description
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It was reported that the expiration date on the blister pack of the topical skin adhesvie package is printed with an expiration date of 8/31/2012, whereas the expiration date on the outside of the box is 2019.There was no patient involvement.
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Manufacturer Narrative
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Product complaint #: (b)(4).Date sent to fda: (b)(4) 2018.The actual sample was received for evaluation.Evaluation of the received sample disclosed that the tyvek label showed an expiration date of (b)(4) 2012 , which is incorrect.Per device history records review, the correct expiration date for subject product code (clr222us) and batch ((b)(4)) combination is (b)(4) 2019.This is considered as incorrect and/or missing labeling condition.
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Search Alerts/Recalls
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