Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspi
FDA device recall Z-0861-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 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, Mexi
- Date initiated
- 2007-03-23
- Date posted
- 2007-06-07
- Date terminated
- 2009-11-16
- Location
- Bannockburn, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| C.P.A.P. NASAL CANNULA (K871157) | Hudson Oxygen Therapy Sales Co. | 1987-04-21 |