Catalog Number 0684-00-0567 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).Device not returned.
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Event Description
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It was reported that prior to use, during the pre-use device inspection, it was noted that the expiration date appeared to be prior to the manufacturing date.There was no reported patient involvement since this occurred prior to use.
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Event Description
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It was reported that prior to use, during the pre-use device inspection, it was noted that the expiration date appeared to be prior to the manufacturing date.There was no reported patient involvement since this occurred prior to use.
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Manufacturer Narrative
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A visual inspection of the returned product determined that the labeling was incorrect.The evaluation confirms that the outside label on the shelf carton had the expiration date prior to the manufacturing date.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
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Search Alerts/Recalls
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