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Terminated

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.

FDA Recall Z-0090-2010 · Posted 2009-10-29

Recall StatusTerminated
Product CodeKDQ
Date Initiated2009-09-21
Date Terminated2011-06-22
Product Quantity823 bottles

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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