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.
- Company
- Ohio Medical Corporation
- Recall Initiated
- September 21, 2009
- Posted
- October 29, 2009
- Terminated
- June 22, 2011
- Recall Number
- Z-0090-2010
- Quantity
- 823 bottles
- Firm Location
- Gurnee, IL
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.
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.
Lot / Code Info
The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
Root Cause
Process control
Action Taken
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.