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U.S. Department of Health and Human Services

Class 2 Device Recall Salter Laboratories Adult Nasal Cannula

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 Class 2 Device Recall Salter Laboratories Adult Nasal Cannulasee related information
Date Initiated by FirmApril 19, 2011
Date PostedMay 23, 2011
Recall Status1 Terminated 3 on August 23, 2011
Recall NumberZ-2242-2011
Recall Event ID 58564
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductSalter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
Code Information Product code 1600-14-50, Lot number 032210 
FEI Number 1314417
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		One complaint received of product in box different from what was on label.
FDA Determined
Cause 2		Other
ActionSalter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication. It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner. No illness or injury would result from this product mix-ups. Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.
Quantity in Commerce3500 pieces
DistributionWorldwide Distribution - USA (nationwide) and the country of South America.
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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