Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
FDA Recall Z-0108-2012 · Posted 2011-10-26
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Recalling FirmSalter Laboratories, Division of Regulatory Affairs
Recall StatusTerminated
Product CodeCCQ
Date Initiated2011-03-25
Date Terminated2011-10-26
Product Quantity9000 all varieties
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.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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