Recall Z-1108-2015 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
| Date | Feb 12, 2015 (initiated Jan 14, 2015) |
| Status | Terminated |
| Reason | The packages may contain foreign material (black particles). |
| Root cause | Material/Component Contamination |
| Action | Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990. |
| Quantity | 15,779,607 units |
| Distribution | Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Urugu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER Respiratory Care, Inc., Dec 16, 1983 |