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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch Neoprene Pecan Shaped Breathing Bag

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  Class 2 Device Recall Rusch Neoprene Pecan Shaped Breathing Bag see related information
Date Initiated by Firm October 31, 2006
Date Posted December 05, 2006
Recall Status1 Terminated 3 on November 30, 2007
Recall Number Z-0244-2007
Recall Event ID 36788
Product Classification Breathing Bag - Product Code BYW
Product Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex Medical, Bannockburn, IL 60015 USA, Made in UK
Code Information Catalog Number (REF) 21176AP, lot number 070318-1
Recalling Firm/
Manufacturer
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall
Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.
FDA Determined
Cause 2
Other
Action Teleflex Medical sent Urgent Medical Device Recall letters dated 10/31/06 via UPS overnight to the direct accounts, informing them that the product was incorrectly labeled as a 1 liter bag when the correct volume of the bag is ¿ liter, and requesting that they cease use of the affected units 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 in Commerce 50 bags
Distribution Nationwide including the states of California and Florida
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.
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