FDA Medical Device Recalls (openFDA)
Ohio Medical Corporation: 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.
- Recall number
- Z-0090-2010
- Recalling firm
- Ohio Medical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2009-09-21
- Posted
- 2009-10-29
- Terminated
- 2011-06-22
- Reason
- 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.
- Root 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
- 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.
- Lot, serial or model codes
- The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 1419185
- Firm city
- Gurnee
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28