Recall Z-2295-2011 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of
| Date | May 26, 2011 (initiated Jan 13, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. |
| Root cause | Other |
| Action | Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427 |
| Distribution | Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992133 | NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL Newport Medical Instruments, Inc., Aug 4, 2000 |