Recall Z-1104-2015
Teleflex Medical · initiated January 14, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. 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.
Codes / lots: Product Code: 006-40C, Lot numbers: 040136, 062136, 029136, 013146, 083146, 178136, 048136, 171136, 074136, 104136, 020146, 060136, 039146, 035136 & 087136.
Reason for recall
The packages may contain foreign material (black particles).
FDA-determined cause: Material/Component Contamination
Action taken
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.
Details
- Recall number
- Z-1104-2015
- Initiated
- January 14, 2015
- Posted by FDA
- February 12, 2015
- Terminated
- December 4, 2017
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- 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, Uruguay and Zambia.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1095-2015 Class II | Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1096-2015 Class II | AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1097-2015 Class II | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1098-2015 Class II | AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1099-2015 Class II | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1100-2015 Class II | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1101-2015 Class II | AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1102-2015 Class II | AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1103-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1105-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1106-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1107-2015 Class II | ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1108-2015 Class II | AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1109-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |