FDA Medical Device Recalls (openFDA)
Salter Labs: 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.
- Recall number
- Z-2093-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-06-25
- Posted
- 2014-07-23
- Terminated
- 2014-09-10
- Reason
- The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
- 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 SVelasquez@us.salterlabs.com, or mail to Salter Labs, attn: Sarah Velasquez, 100 W. Sycamore Rd. Arvin, CA 93203.
- Quantity
- 584 units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
- Lot, serial or model codes
- Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BYG
- Firm FEI
- 1314417
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28