Z-0697-06

Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211

Name: Z-0697-06 Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
Creator: Fisher & Paykel Healthcare Inc
Published: 2005-12-20
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2005-12-20 / Terminated / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare Inc began a recall of Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211 on 2005-12-20. The reason FDA records is "Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire". 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-0697-06
Status: Terminated
Initiated: 2005-12-20
Posted: 2006-03-29
Terminated: 2012-04-19
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
Quantity in commerce: 341boxes (3,410 pcs)
Distribution: Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
Product codes and lots: Affected lots for all catalogue numbers: 041101-050331(inclusive).

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)