FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Inc: 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.
- Recall number
- Z-0414-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-10-22
- Posted
- 2008-12-10
- Terminated
- 2012-03-26
- Reason
- 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
- 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
- 229,320 units
- Distribution
- Worldwide Distribution including US and country of Canada.
- Lot, serial or model codes
- Lot Number: All lot numbers up to and including Lot 080627.
- 510(k) numbers
- ["K983112"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3000210616
- Firm city
- Huntington Beach
- 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
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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