Z-2093-2014Class II

Oxygen Mask, Model No. 8120-7

Name: Z-2093-2014 Oxygen Mask, Model No. 8120-7
Creator: Salter Labs
Published: 2014-06-25
License: https://open.fda.gov/license/

Salter Labs / initiated 2014-06-25 / Terminated / root cause: labeling and UDI

FDA source

Salter Labs began a recall of Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation... on 2014-06-25. FDA classified it as Class II and gives the reason as "The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2093-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-07-23
Terminated: 2014-09-10
Recalling firm: Salter Labs
Product: Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Product code: BYG Mask, Oxygen
Reason for recall: The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Salter Labs sent a Medical Device Recall letter dated June 25, 2014 to all affected customers. The letter identified the affected product, problems and actions to be taken. Customers are instructed to complete the attached Return Response Form and return it to Salter as soon as possible. Customers are instructed to send completed form to Salter by either Fax (800) 628-4690, attn: Sarah Velasquez, email to [email protected], or mail to Salter Labs, attn: Sarah Velasquez, 100 W. Sycamore Rd. Arvin, CA 93203.
Quantity in commerce: 584 units
Distribution: Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
Product codes and lots: Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2093-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2093-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22

Product code BYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)