Class 2 Device Recall Boehringer Suction Regulator

• Date Initiated by Firm: August 01, 2005
• Date Posted: November 17, 2005
• Recall Status: Terminated on November 16, 2005
• Recall Number: Z-0155-06
• Recall Event ID: 32810
• 510(K)Number: K853095
• Product Classification: Regulator, Vacuum - Product Code KDP
• Product: Boehringer Suction Regulator Model number 3704
• Code Information: Lot numbers 05F and 05G
• Recalling Firm/ Manufacturer: Boehringer Laboratories, Inc.; 500 E Washington St; Norristown PA 19401-5149
• For Additional Information Contact: John Karpowicz; 610-278-0900
• Manufacturer Reason for Recall: Condition exists that prevents complete shutoff of the valve
• FDA Determined Cause: Other
• Action: The recalling firm telephoned their customers on 7/25/05 to inform them of the problem, request the return of the recalled product, and inform them that replacement products were being shipped
• Quantity in Commerce: 1829 units
• Distribution: The products were shipped to hospitals AZ, AK, CA, FL, LA, MI, MO, NC, NJ, OR, PA, SC, UT, VA, and WA.
• 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 = KDP