Model Number 63441E |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the lativian translation of the gp plus burette set, 60dpm, 3 ss y label incorrectly stated that "natural rubber latex" and "dehp" were not part of the material.The following information was provided by the initial reporter: "mistake in the latvian translation of ¿natural rubber latex is not part of the material¿.The latvian translation appears to state that there is also no dehp in the product.This is contrary to the ¿contains dehp¿ symbol located on the dfu.".
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Event Description
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It was reported that the lativian translation of the gp plus burette set, 60dpm, 3 ss y label incorrectly stated that "natural rubber latex" and "dehp" were not part of the material.The following information was provided by the initial reporter: "mistake in the latvian translation of ¿natural rubber latex is not part of the material¿.The latvian translation appears to state that there is also no dehp in the product.This is contrary to the ¿contains dehp¿ symbol located on the dfu.".
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Manufacturer Narrative
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Correction: after further review, it was found that is not a 510k product.This complaint will be cancelled.
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Search Alerts/Recalls
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