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 Date 12/07/2017 |
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 an expired topical skin adhesive product was received by the customer.The expiration date on the contents is 8/31/2012.There were no patient consequences reported.
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Manufacturer Narrative
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Product complaint # (b)(4).The actual sample was received for evaluation.The evaluation of the received sample disclosed that the tyvek label showed an expiration date of 2012-08-31, which is incorrect.Per dhr 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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