Recall Z-0555-04 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Instrumentation Industries Inc
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
| Date | Feb 27, 2004 (initiated Sep 12, 2003) |
| Status | Terminated |
| Reason | possible external debris in the on/off plunger. |
| Root cause | Other |
| Action | The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately. |
| Quantity | 46 units |
| Distribution | The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR Instrumentation Industries, Inc., Aug 17, 1999 |