| Class 2 Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL | |
Date Initiated by Firm | December 01, 2005 |
Date Posted | February 08, 2006 |
Recall Status1 |
Terminated 3 on May 11, 2006 |
Recall Number | Z-0503-06 |
Recall Event ID |
34120 |
Product Classification |
Humidifier, Respiratory Gas, (Direct Patient Interface) - Product Code BTT
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Product | 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 |
Code Information |
catalog number 037-00, lot 150150, exp. 2009-10 |
Recalling Firm/ Manufacturer |
Teleflex Medical 2345 Waukegan Rd Ste 120 Bannockburn IL 60015-1580
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For Additional Information Contact | Ms. Julie McDowell 610-948-2836 |
Manufacturer Reason for Recall | Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements. |
FDA Determined Cause 2 | 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 in Commerce | 1050 units |
Distribution | Colorado, Nebraska, Oregon, Minnesota, California, Pennsylvania, Michigan, Louisiana, Oklahoma and Texas. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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