Recall Z-2237-2011 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Salter Laboratories, Division of Regulatory Affairs
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.
| Date | May 20, 2011 (initiated Apr 19, 2011) |
| Status | Terminated |
| Reason | Complaint received that the product in the box was different from labeled product. |
| Root cause | 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 |
| Quantity | 22,150 pieces |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA Salter Labs, Jul 24, 1989 |