BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
FDA device recall Z-0555-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- Instrumentation Industries Inc
- Reason for recall
- possible external debris in the on/off plunger.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 46 units
- Distribution
- The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.
- Date initiated
- 2003-09-12
- Date posted
- 2004-02-27
- Date terminated
- 2004-02-26
- Location
- Bethel Park, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR (K991785) | Instrumentation Industries, Inc. | 1999-08-17 |