Z-1112-2020Class I

HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

Name: Z-1112-2020 HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Creator: Teleflex Medical Inc
Published: 2019-12-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2019-12-13 / Terminated / root cause: design

FDA source

TELEFLEX MEDICAL INC began a recall of HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit on 2019-12-13. FDA classified it as Class I and gives the reason as "There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1112-2020
Classification: Class I
Status: Terminated
Initiated: 2019-12-13
Posted: 2020-02-07
Terminated: 2024-04-30
Recalling firm: Teleflex Medical
Product: HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated the recall by letter on 12/13/2019. The firm is seeking the return of the product. The firm requested the following actions be taken: "1. If you have affected stock, immediately identify all patients that are currently exposed to use of this product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 30566 devices
Distribution: nationwide
Product codes and lots: GTIN 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1112-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1113-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1114-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07
Z-1115-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code BTT

K162242Class IIComfort Flo Humidification SystemTeleflexmedical, Inc. / cleared 2017-01-19

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)