Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) sup

FDA device recall Z-2093-2014 · posted 2014-07-23 · Terminated

Recall details

Recalling firm

Salter Labs

Reason for recall

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

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

BYG

Quantity affected

584 units

Distribution

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

Date initiated

2014-06-25

Date posted

2014-07-23

Date terminated

2014-09-10

Location

Carlsbad, CA