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Nebulizer Kit

Chen Qian Electronic Commerce (Hangzhou) Co., Ltd. · Model OWWHQ-1901PT(408D) · UDI-DI 06973401840022

BYG Prescription
10
510(k) clearances
500
Adverse events (9 deaths)
41
Recalls
269
Facilities

Description

Nebulizer Machine Mask parts, cool mist inhaler accessories tubing, mask kit, including tunbing (74 inch), mask for kids, mask for adult, mouthpiece by only warm.

Recalls

DateFirmReason
2025-11-21Medline Industries, LPFirm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortnes
2018-07-11POM Medical LLCComplaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port.
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, IncReports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, Inc
2017-05-10ConvaTec, Inc

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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.