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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
2013-05-15Z-1682-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution356,728 unitsclearance family
2013-05-15Z-1683-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution530,488 unitsclearance family
2013-05-15Z-1684-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution249,576 unitsclearance family
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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