Teleflex Medical 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Teleflex Medical
Lot Codes / Batch Numbers
Catalog Number (REF) 21176AP, lot number 070318-1
Products Sold
Catalog Number (REF) 21176AP, lot number 070318-1
Teleflex Medical is recalling Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebre due to Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026