Z-0414-2009

Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory...

Name: Z-0414-2009 Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory...
Creator: Fisher & Paykel Healthcare Inc
Published: 2008-10-22
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2008-10-22 / Terminated / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare Inc began a recall of Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of... on 2008-10-22. The reason FDA records is "The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0414-2009
Status: Terminated
Initiated: 2008-10-22
Posted: 2008-12-10
Terminated: 2012-03-26
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of the humidified gas, to reduce condensation.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Fisher & Paykel Healthcare, Inc. (FPH) issued an URGENT-PRODUCT RECALL letter (dated October 8, 2008) including a Customer recall letter for consignees/customers to Cardinal Health. Cardinal Health will, in turn, send the Customer recall letter dated October 10, 2008 to its consignees/customers. Fisher & Paykel Healthcare (FPH) also issued a similar set of recall notification letters to Norco on October 15, 2008. Recipients of the recall letter must perform the following: 1) Check all Cardinal Health stock of the product for the affected lots, 2) Immediately quarantine the affected product, 3) Complete a Device Recall Response Sheet, and 4) Fax or e-mail the completed Device Recall Response Sheet. Fisher & Paykel Healthcare, Inc.'s "Dear Customer Letter" for Cardinal Health and Norco instructs consignees to complete a customer response (i.e. fax enclosed Customer Acknowledgement Form) to FPH. The customer letter also provides instructions for product return. Fisher & Paykel Healthcare, Inc. recall communication instructions to Cardinal Health and Norco was for all affected product to be returned and quarantined by the distributors. The distributors will return any affected stock to Fisher & Paykel Healthcare, Inc. for documented destruction.
Quantity in commerce: 229,320 units
Distribution: Worldwide Distribution including US and country of Canada.
Product codes and lots: Lot Number: All lot numbers up to and including Lot 080627.

Product code BTT

K983112Class IIRespiratory Humidifier, Model # Mr850Fisher & Paykel Healthcare, Ltd. / cleared 1998-11-10

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)