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 12/18/2017 |
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 sales rep that the facility reported that the product box has an expiration date of 2019 and the device packaging has an expiration date of 08/31/2012.No patient involvement.Twenty one devices will be returned.
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Manufacturer Narrative
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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 (b)(4) and batch (b)(4) combination is 08/16/2019.This is considered as incorrect and/or missing labeling condition.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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