Recall Z-2242-2011 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Salter Laboratories, Division of Regulatory Affairs
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.
| Date | May 23, 2011 (initiated Apr 19, 2011) |
| Status | Terminated |
| Reason | One complaint received of product in box different from what was on label. |
| Root cause | Other |
| 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 | 3500 pieces |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of South America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.