Recall Z-0503-06 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Teleflex Medical
AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00
| Date | Feb 8, 2006 (initiated Dec 1, 2005) |
| Status | Terminated |
| Reason | Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements. |
| Root cause | Other |
| Action | Teleflex Medical sent recall letters dated 12/1/05 to their direct accounts on the same date via UPS overnight. The accounts were informed that the lot did not pass validated sterility test requirements, and were instructed to cease distribution and use of the lot and quarantine it for return to Teleflex Medical, Durham, NC. The wholesalers were requested to notify their customers of the recall and have them return their inventory of the lot to the direct account for consolidation and return to Teleflex. Questions were directed to Dan Daily at 1-800-334-9751, ext. 4948. |
| Quantity | 1050 units |
| Distribution | Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.