Class 2 Device Recall Suction Regulator

• Date Initiated by Firm: May 19, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 14, 2004
• Recall Number: Z-1231-04
• Recall Event ID: 29184
• Product Classification: Apparatus, Suction, Operating-Room, Wall Vacuum Powered - Product Code GCX
• Product: Boheringer Suction Regulator Model 7702L, Lot number 04D Boehinger Replacement Gauge, Model 9071, Lot number 200405.
• Code Information: Regulator Model 7702L, Lot Number 04D
• FEI Number: 2518417
• Recalling Firm/ Manufacturer: Boehringer Laboratories Inc; 500 E Washington St; Norristown PA 19401-5149
• For Additional Information Contact: John Karpowicz; 800-642-4945
• Manufacturer Reason for Recall: The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
• FDA Determined Cause: Other
• Action: All direct accounts were contacted by the recalling firm''s Customer Service Representative to determine the location of the affected product. The CSR arrange for replacement proudct.
• Quantity in Commerce: 56 units
• Distribution: The recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN,
• 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.