Recall Z-0553-05 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Fisher & Paykel Healthcare Inc
RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
| Date | Feb 18, 2005 (initiated Dec 21, 2004) |
| Status | Terminated |
| Reason | Pressure elbow may be partly occluded. |
| Root cause | Other |
| Action | Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied. |
| Quantity | 2200 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 Fisher & Paykel Healthcare, Ltd., Jul 7, 2003 |