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 12/04/2017 |
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 product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by the facility that the packaging for the device has an expiration date of 2012 but the box has an expiration date of 2019.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Date sent to fda: 2/5/2018 additional evaluation summary: evaluation of the received sample disclosed that the tyvek label showed an expiration date of 2012-08-31, which is incorrect.Per device history records 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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