FDA Medical Device Recalls (openFDA)
Teleflex Medical: Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1694: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;
- Recall number
- Z-0861-2007
- Recalling firm
- Teleflex Medical
- Product
- Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1694: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;
- Status
- Terminated
- Initiated
- 2007-03-23
- Posted
- 2007-06-07
- Terminated
- 2009-11-16
- Reason
- The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
- Root cause
- Other
- Action
- Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
- Quantity
- 13,530 for all products
- Distribution
- Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela
- Lot, serial or model codes
- Catalog no. 1694, lot numbers 32069/21406, 33069/22306
- 510(k) numbers
- ["K871157"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 3004959265
- Firm city
- Bannockburn
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28