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Provox ShowerAid

Atos Medical AB · Model 7260 · UDI-DI 07331791001680

BYD

510(k) clearances

440

Adverse events (11 deaths)

Recalls

124

Facilities

Description

Provox ShowerAid is used to temporarily replace the HME during showering. The ShowerAid can be placed in all Provox appliance holders.

Recalls

Date	Firm	Reason
2024-07-18	Smiths Medical ASD Inc.	Uncertainty in the seal integrity of the sterile packaging.
2024-07-18	Smiths Medical ASD Inc.	Uncertainty in the seal integrity of the sterile packaging.
2024-07-18	Smiths Medical ASD Inc.	Uncertainty in the seal integrity of the sterile packaging.
2022-04-11	TELEFLEX MEDICAL INC	Reports received of torn corrugated breathing tubes.
2021-03-29	Atos Medical AB	Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
2020-09-04	AB ULAX	Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may
2015-12-03	Teleflex Medical	Cracking may occur at the 15mm and 22mm ISO female connector.
2015-12-03	Teleflex Medical	Cracks may occur at the 15mm and 22mm ISO female connector.
2015-02-19	Arc Medical Inc	Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
2015-01-12	Teleflex Medical	Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.