Recall Z-0414-2009 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
| Date | Dec 10, 2008 (initiated Oct 22, 2008) |
| Status | Terminated |
| 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 |
| Quantity | 229,320 units |
| Distribution | Worldwide Distribution including US and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983112 | RESPIRATORY HUMIDIFIER, MODEL # MR850 Fisher & Paykel Healthcare, Ltd., Nov 10, 1998 |