Recall Z-2093-2014 ยท BYG Mask, Oxygen
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.
| Date | Jul 23, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.