Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. lntended Use: The dual heated adult respiratory ventilator

FDA device recall Z-0414-2009 · posted 2008-12-10 · Terminated

Recall details

Recalling firm

Fisher & Paykel Healthcare Inc

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.

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

BTT

Quantity affected

229,320 units

Distribution

Worldwide Distribution including US and country of Canada.

Date initiated

2008-10-22

Date posted

2008-12-10

Date terminated

2012-03-26

Location

Huntington Beach, CA

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