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U.S. Department of Health and Human Services

Class 2 Device Recall Nasal Cannula (Adult) Salter Style

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  Class 2 Device Recall Nasal Cannula (Adult) Salter Style see related information
Date Initiated by Firm April 19, 2011
Date Posted May 20, 2011
Recall Status1 Terminated 3 on August 23, 2011
Recall Number Z-2237-2011
Recall Event ID 58563
510(K)Number K892406  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula.
Single Patient Use. Do not Sterilize
Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293

Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
Code Information Product Code: 4707-7-7-25, Lot code 012411
Recalling Firm/
Manufacturer		 Salter Laboratories, Division of Regulatory Affairs
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information Contact Michael Shoup
661-854-6871
Manufacturer Reason
for Recall		 Complaint received that the product in the box was different from labeled product.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 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 22,150 pieces
Distribution Nationwide distribution.
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.
510(K) Database 510(K)s with Product Code = CCK and Original Applicant = SALTER LABS
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