Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

New Search Back To Search Results
 

Medical Device Recalls
Class 2 Recall
Rusch Neoprene Pecan Shaped Breathing Bag

See Related Information
Date Recall
Initiated		 October 31, 2006
Date Posted December 05, 2006
Recall Number Z-0244-2007
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 , Illinois 60015-1580
For Addition Information Contact Ms. Julie McDowell
610-948-2836
Reason For
Recall		 Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.
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
 

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH