Recall Z-0697-06 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Fisher & Paykel Healthcare Inc
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
| Date | Mar 29, 2006 (initiated Dec 20, 2005) |
| Status | Terminated |
| 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 |
| 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 |