Date Initiated by Firm |
September 12, 2003 |
Date Posted |
February 27, 2004 |
Recall Status1 |
Terminated 3 on February 26, 2004 |
Recall Number |
Z-0556-04 |
Recall Event ID |
27419 |
Product Classification |
Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
|
Product |
BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge. |
Code Information |
Part number BE183-SUR, Lot number P0908103 |
Recalling Firm/ Manufacturer |
Instrumentation Industries Inc 2990 Industrial Blvd Bethel Park PA 15102
|
For Additional Information Contact |
Tricia Wood 412-854-1133 Ext. 433
|
Manufacturer Reason for Recall |
possible external debris in the on/off plunger.
|
FDA Determined Cause 2 |
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 in Commerce |
46 units |
Distribution |
The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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