Class 2 Device Recall BE 183 SU Manual Jet Ventilator

• Date Initiated by Firm: September 12, 2003
• Date Posted: February 27, 2004
• Recall Status: Terminated on February 26, 2004
• Recall Number: Z-0555-04
• Recall Event ID: 27419
• 510(K)Number: K991785
• Product Classification: Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
• Product: BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
• Code Information: Part number BE 183-SU, Lot number P0907203
• 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: 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

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.

• 510(K) Database: 510(K)s with Product Code = BTM