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U.S. Department of Health and Human Services

Class 2 Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL

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  Class 2 Device Recall AquaPak Sterile Water for Inhalation, USP, 760 mL see related information
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
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/
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
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
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

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.