Recall Z-0436-06 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Smiths Medical PM, Inc.
Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.
| Date | Jan 24, 2006 (initiated Dec 5, 2005) |
| Status | Terminated |
| Reason | A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose. |
| Root cause | Other |
| Action | Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair. |
| Quantity | 44 |
| Distribution | CA, CO, IN,MN, NY, PA, TN, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.