FDAJanuary 9, 2025device
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
What to do
FDA enforcement status: Ongoing
Brands named
kung shin plasticskungkung shin
UPCs
00810050852210
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSchool Specialty Recalls Tip Restraint Kits Included in Childcraft Furniture Due to Risk of Serious Injury or Death from Tip-Over Hazard2026-06-11
- FDACircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)2025-01-09
- CPSCWalmart Recalls Mainstays Electric Mini Choppers Due to Laceration Hazard; Sold Exclusively at Walmart2024-04-04
- CPSCClark Associates Recalls Lancaster Table & Seating Brand Allegro Plastic Side Chairs Due to Fall Hazard2024-01-25
- CPSCPearl River Propane Hoses Sold with Flame King Torches and Accessories Recalled Due to Fire Hazard2021-12-22
- FDAEndocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds2020-03-11
- CPSCConfer Plastics Recalls Pool Step Systems Due to Entrapment and Drowning Hazard2018-08-21
- CPSCBurton Recalls Snowboard Boots Due to Fall Hazard (Recall Alert)2018-07-11
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