Z-0553-05

RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier

Name: Z-0553-05 RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier
Creator: Fisher & Paykel Healthcare Inc
Published: 2004-12-21
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2004-12-21 / Terminated

FDA source

Fisher & Paykel Healthcare Inc began a recall of RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier on 2004-12-21. The reason FDA records is "Pressure elbow may be partly occluded". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0553-05
Status: Terminated
Initiated: 2004-12-21
Posted: 2005-02-18
Terminated: 2005-11-21
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Pressure elbow may be partly occluded.
FDA root cause: Other
Action: Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied.
Quantity in commerce: 2200
Distribution: Worldwide
Product codes and lots: Lot umbers in the range 040701 to 041216

Product code BTT

K020332Class IIRespiratory Humidifier, Model Mr850Fisher & Paykel Healthcare, Ltd. / cleared 2003-07-07

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)