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U.S. Department of Health and Human Services

Class 2 Device Recall BE 183 Series Manual Jet Ventilator with Regulator and Gauge.

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 Class 2 Device Recall BE 183 Series Manual Jet Ventilator with Regulator and Gauge.see related information
Date Initiated by FirmSeptember 12, 2003
Date PostedFebruary 27, 2004
Recall Status1 Terminated 3 on February 26, 2004
Recall NumberZ-0556-04
Recall Event ID 27419
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
ProductBE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
Code Information Part number BE183-SUR, Lot number P0908103
FEI Number 2518436
Recalling Firm/
Manufacturer		 Instrumentation Industries Inc
2990 Industrial Blvd
Bethel Park PA 15102
For Additional Information ContactTricia Wood
412-854-1133 Ext. 433
Manufacturer Reason
for Recall		possible external debris in the on/off plunger.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce46 units
DistributionThe products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.
Total Product Life CycleTPLC Device Report
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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