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U.S. Department of Health and Human Services

Class 2 Device Recall Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.

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 Class 2 Device Recall Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit.see related information
Date Initiated by FirmOctober 22, 2008
Date PostedDecember 10, 2008
Recall Status1 Terminated 3 on March 26, 2012
Recall NumberZ-0414-2009
Recall Event ID 50105
510(K)NumberK983112 
Product Classification Respiratory Gas Humidifier (Direct Patient Interface). - Product Code BTT
ProductFisher & 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.
Code Information Lot Number: All lot numbers up to and including Lot 080627.
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare Inc
5900 Skylab Rd
Huntington Beach CA 92647-2061
For Additional Information Contact
949-453-4000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process change control
ActionFisher & 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 in Commerce229,320 units
DistributionWorldwide Distribution including US and country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BTT
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