Rusch (Latex Free) Neoprene Pecan Shaped Breathing Bag with 15 mm neck insert, size 1 liter; a rebreathing bag; Teleflex

FDA device recall Z-0244-2007 · posted 2006-12-05 · Terminated

Recall details

Recalling firm

Teleflex Medical

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 taken

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.

Root cause

Other

Status

Terminated

Product code

BYW

Quantity affected

50 bags

Distribution

Nationwide including the states of California and Florida

Date initiated

2006-10-31

Date posted

2006-12-05

Date terminated

2007-11-30

Location

Bannockburn, IL