Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
FDA device recall Z-2005-2014 · posted 2014-07-07 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Action taken
- Consignees were notified by letter on 06/06/2014.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 7,758,650 ea. (total for all types listed)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
- Date initiated
- 2014-06-05
- Date posted
- 2014-07-07
- Date terminated
- 2015-07-02
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUAPAK 020 HUMIDIFIER ADAPTER (K833974) | Respiratory Care, Inc. | 1983-12-16 |