—#49359

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

FDA product code: BYW — Device, Rebreathing
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Catalog Number (REF) 21176AP, lot number 070318-1

Why it was recalled

Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Nationwide including the states of California and Florida

Timeline

Recall initiated: 2006-10-31
Posted by FDA: 2006-12-05
Terminated: 2007-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49359. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.