FDA Recall Terminated

Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs; Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

Recall: Z-0110-2012 · Initiated March 25, 2011

Recall

Recall Number: Z-0110-2012
Event Number: 58454
Firm: Salter Laboratories, Division of Regulatory Affairs
FEI Number: 1314417
Product Code: BYG
Status: Terminated
Root Cause: Equipment maintenance
Initiated: March 25, 2011
Posted: October 26, 2011
Terminated: October 26, 2011
Address: 100 Sycamore Rd, Arvin, CA, 93203-2300

Description

Reason

A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.

Action

The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Distribution

Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.

Quantity

1300 all varieties