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U.S. Department of Health and Human Services

Class 2 Device Recall Mask adult, oxygen, medium concentration, nonbreathing

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  Class 2 Device Recall Mask adult, oxygen, medium concentration, nonbreathing see related information
Date Initiated by Firm March 25, 2011
Date Posted October 26, 2011
Recall Status1 Terminated 3 on October 26, 2011
Recall Number Z-0110-2012
Recall Event ID 58454
Product Classification Mask, oxygen - Product Code BYG
Product Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs;
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety vent - 50/cs;
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/7' tube and safety vent - 50/cs;

Salter Labs, Arvin, CA 93203

Intended usage: respiratory therapy.
Code Information Lot 031411; Product code: 8130-9-25; Product code: 8130-0-50; Product Code: E8139-7-50.
Recalling Firm/
Manufacturer		 Salter Laboratories, Division of Regulatory Affairs
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information Contact Gus Bock
661-854-6871
Manufacturer Reason
for Recall		 A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
FDA Determined
Cause 2		 Equipment maintenance
Action The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.
Quantity in Commerce 1300 all varieties
Distribution Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
Total Product Life Cycle TPLC 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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