FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Inc: Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
- Recall number
- Z-0697-06
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Product
- Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
- Status
- Terminated
- Initiated
- 2005-12-20
- Posted
- 2006-03-29
- Terminated
- 2012-04-19
- Reason
- 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
- 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
- 341boxes (3,410 pcs)
- Distribution
- Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
- Lot, serial or model codes
- Affected lots for all catalogue numbers: 041101-050331(inclusive).
- 510(k) numbers
- ["K983112"]
- 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