Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
FDA device recall Z-0697-06 · posted 2006-03-29 · Terminated
Recall details
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 341boxes (3,410 pcs)
- Distribution
- Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
- Date initiated
- 2005-12-20
- Date posted
- 2006-03-29
- Date terminated
- 2012-04-19
- 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 (K983112) | Fisher & Paykel Healthcare, Ltd. | 1998-11-10 |