• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Salter Laboratories Adult Nasal Cannula
see related information
Date Posted May 23, 2011
Recall Number Z-2242-2011
Product Salter 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
Recalling Firm/
Manufacturer
Salter Laboratories, Division of Regulatory Affairs
100 Sycamore Rd
Arvin, California 93203-2300
For Additional Information Contact Michael Shoup
661-854-6871
Reason for
Recall
One complaint received of product in box different from what was on label.
Action Salter 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 Commerce 3500 pieces
Distribution Worldwide Distribution - USA (nationwide) and the country of South America.
 
-
-