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.
FDA Recall Z-2237-2011 · Posted 2011-05-20
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Recalling FirmSalter Laboratories, Division of Regulatory Affairs
Recall StatusTerminated
Product CodeCCK
Date Initiated2011-04-19
Date Terminated2011-08-23
Product Quantity22,150 pieces
Reason for Recall
Complaint received that the product in the box was different from labeled product.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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