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Class 2 Device Recall Oxygen Mask |
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Date Initiated by Firm |
June 25, 2014 |
Date Posted |
July 23, 2014 |
Recall Status1 |
Terminated 3 on September 10, 2014 |
Recall Number |
Z-2093-2014 |
Recall Event ID |
68701 |
Product Classification |
Mask, oxygen - Product Code BYG
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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. |
Code Information |
Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614 |
Recalling Firm/ Manufacturer |
Salter Labs 2365 Camino Vida Carlsbad CA 92011
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Manufacturer Reason for Recall |
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
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FDA Determined Cause 2 |
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 in Commerce |
584 units |
Distribution |
Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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