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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-02-23Z-1450-2024Class IIOpen, ClassifiedProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada.270 unitscode info di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-02-10NAINo action indicatedCenturion Medical Products, LP0
2022-04-05NAINo action indicatedCenturion Medical Products, LP0
2020-06-11WLWarning LetterCenturion Medical Products, LP—
2019-11-01OAIOfficial action indicatedCenturion Medical Products, LP5
2019-08-20OAIOfficial action indicatedCenturion Medical Products, LP5
2018-08-17NAINo action indicatedCenturion Medical Products LP0
2018-06-26NAINo action indicatedCenturion Medical Products, LP0
2018-01-31NAINo action indicatedCenturion Medical Products, LP0
2016-09-28VAIVoluntary action indicatedCenturion Medical Products, LP8
2015-09-21VAIVoluntary action indicatedCenturion Medical Products, LP1
2015-03-31VAIVoluntary action indicatedCenturion Medical Products LP4
2015-03-26OAIOfficial action indicatedCenturion Medical Products, LP0
2013-11-18VAIVoluntary action indicatedCenturion Medical Products, LP0
2013-03-19VAIVoluntary action indicatedCenturion Medical Products, LP5
2012-06-29VAIVoluntary action indicatedCenturion Medical Products, LP0
2011-06-02NAINo action indicatedCenturion Medical Products, LP0
2010-06-28VAIVoluntary action indicatedCenturion Medical Products LP8
2010-03-08NAINo action indicatedCenturion Medical Products, LP0
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