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Terminated

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.

FDA Recall Z-2093-2014 · Posted 2014-07-23

Recalling FirmSalter Labs
Recall StatusTerminated
Product CodeBYG
Date Initiated2014-06-25
Date Terminated2014-09-10
Product Quantity584 units

Reason for Recall

The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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