FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Inc: RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
- Recall number
- Z-0553-05
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Product
- RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
- Status
- Terminated
- Initiated
- 2004-12-21
- Posted
- 2005-02-18
- Terminated
- 2005-11-21
- Reason
- Pressure elbow may be partly occluded.
- 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
- 2200
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot umbers in the range 040701 to 041216
- 510(k) numbers
- ["K020332"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3000210616
- Firm city
- Laguna Hills
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28