RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.
FDA device recall Z-0553-05 · posted 2005-02-18 · Terminated
Recall details
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Reason for recall
- Pressure elbow may be partly occluded.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 2200
- Distribution
- Worldwide
- Date initiated
- 2004-12-21
- Date posted
- 2005-02-18
- Date terminated
- 2005-11-21
- Location
- Laguna Hills, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESPIRATORY HUMIDIFIER, MODEL MR850 (K020332) | Fisher & Paykel Healthcare, Ltd. | 2003-07-07 |