Z-1268-2025Class II

CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and...

Name: Z-1268-2025 CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and...
Creator: Kung Shin Plastics Co. Ltd.
Published: 2025-01-09
License: https://open.fda.gov/license/

Kung Shin Plastics Co. Ltd. / initiated 2025-01-09 / Open, Classified / root cause: manufacturing process

FDA source

Kung Shin Plastics Co. Ltd. began a recall of CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) on 2025-01-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1268-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-09
Posted: 2025-03-04
Recalling firm: Kung Shin Plastics Co. Ltd.
Product: CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On January 9, 2025, the firm sent a recall notice to their sole distributor in the US, followed by a more detailed notice on January 10. Customers were instructed to locate and immediately discontinue use of affected products. Affected product should be quarantined and returned. If products of affected batches have been sold, the distributor should immediately notify the buyers to stop using them, quarantine them, and destroy them.
Quantity in commerce: 50000 ea/ 500 cases
Distribution: US Nationwide distribution in the state of IL.
Product codes and lots: UDI (01)00810050852210(10)C2O24002(11)240626(17)290625 Lot C2O24002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-04
Z-1269-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-04

Product code CAH

K032878Class IIKung Shin, Hmef Sk203Kung Shin Plastics Co., Ltd. / cleared 2004-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)