Recall Z-0272-2016 ยท CAN Regulator, Pressure, Gas Cylinder
Precision Medical, Inc.
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
| Date | Nov 13, 2015 (initiated Oct 8, 2015) |
| Status | Terminated |
| Reason | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25). |
| Root cause | Error in labeling |
| Action | The firm sent "Attention Field Corrective Action" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly. |
| Quantity | 315 |
| Distribution | Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901831 | PRECISION MEDICAL OXYGEN REGULATOR Precision Medical, Inc., Aug 14, 1990 |