Z-0112-2012

Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter...

Name: Z-0112-2012 Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter...
Creator: Salter Laboratories, Division of Regulatory Affairs
Published: 2011-03-25
License: https://open.fda.gov/license/

Salter Labs / initiated 2011-03-25 / Terminated / root cause: manufacturing process

FDA source

Salter Laboratories, Division of Regulatory Affairs began a recall of Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory... on 2011-03-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0112-2012
Status: Terminated
Initiated: 2011-03-25
Posted: 2011-10-26
Terminated: 2011-10-26
Recalling firm: Salter Labs
Product: Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
Product code: BYF Mask, Oxygen, Low Concentration, Venturi
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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.
Quantity in commerce: 800 all varieties
Distribution: Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Product codes and lots: Lot 022611; Product code: L150-7-50

Product code BYF

K772127Class IOxygen Mask, Air-EntrainmentSalter Labs / cleared 1978-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)