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 11/07/2017 |
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.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.The expiration date on the contents is (b)(6) 2012.There were no patient consequences reported.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Evaluation summary ¿ the actual sample was received for evaluation.The evaluation of the received sample disclosed that the tyvek label showed an expiration date of (b)(4) 2012, which is incorrect.Per (b)(4) review, the correct expiration date for subject product code ((b)(4)) 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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