DUREX Avanti Bare- RealFeel Non-Latex Condom · recalls, adverse events, clearances

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

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2018-12-19	Z-0993-2019	Class II	Terminated	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.Distribution: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.	1761044	clearance family
2018-12-19	Z-0994-2019	Class II	Terminated	Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.Distribution: Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.	34920	clearance family
2018-08-06	Z-0091-2019	Class II	Terminated	Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-lifeDistribution: US in the states of NY	34 cartons/12 condoms each (408 condoms total)	clearance family
2018-07-23	Z-3241-2018	Class II	Terminated	The products failed the filed specification of 1.0kPa for Burst Pressure.Distribution: US Nationwide.	487980 condoms	clearance family

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-05-15	NAI	No action indicated	RB Health (US) LLC	0

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