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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 Stylesee related information
Date Initiated by FirmApril 19, 2011
Date PostedMay 20, 2011
Recall Status1 Terminated 3 on August 23, 2011
Recall NumberZ-2237-2011
Recall Event ID 58563
510(K)NumberK892406 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductNasal 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 ContactMichael 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
ActionThe 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 Commerce22,150 pieces
DistributionNationwide distribution.
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.
510(K) Database510(K)s with Product Code = CCK
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