Class 2 Device Recall Vacuum Collection Bottle

• Date Initiated by Firm: September 21, 2009
• Date Posted: October 29, 2009
• Recall Status: Terminated on June 22, 2011
• Recall Number: Z-0090-2010
• Recall Event ID: 53192
• Product Classification: Bottle, collection, vacuum - Product Code KDQ
• Product: Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: ; 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float;; 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float;; 6700-0370-800 - Bottle with Floor Bracket, Cap & Float.; ; The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
• Code Information: The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
• Recalling Firm/ Manufacturer: Ohio Medical Corporation; 1111 Lakeside Dr; Gurnee IL 60031
• For Additional Information Contact: Ms. Anita Christ; 800-448-0770
• Manufacturer Reason for Recall: The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
• FDA Determined Cause: Process control
• Action: Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.
• Quantity in Commerce: 823 bottles
• Distribution: Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.
• 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.