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U.S. Department of Health and Human Services

Class 2 Device Recall Oxygen Mask

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 Class 2 Device Recall Oxygen Masksee related information
Date Initiated by FirmJune 25, 2014
Date PostedJuly 23, 2014
Recall Status1 Terminated 3 on September 10, 2014
Recall NumberZ-2093-2014
Recall Event ID 68701
Product Classification Mask, oxygen - Product Code BYG
ProductOxygen 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
FEI Number 1314417
Recalling Firm/
Manufacturer		 Salter Labs
2365 Camino Vida
Carlsbad CA 92011
Manufacturer Reason
for Recall		The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
FDA Determined
Cause 2		Error in labeling
ActionSalter 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 Commerce584 units
DistributionWorldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.
Total Product Life CycleTPLC Device Report
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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