Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs; Salter Labs, Arvin, CA 93203 Intended

FDA device recall Z-0111-2012 · posted 2011-10-26 · Terminated

Recall details

Recalling firm

Salter Laboratories, Division of Regulatory Affairs

Reason for recall

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 taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

BYG

Quantity affected

200 all varieties

Distribution

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

Date initiated

2011-03-25

Date posted

2011-10-26

Date terminated

2011-10-26

Location

Arvin, CA