Recall Z-0089-2010
Ohio Medical Corporation · initiated September 21, 2009
Product
Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
Codes / lots: The bottles have a date stamp on the bottom which consists of a clock dial and a two digit number in the middle with an arrow pointing to the hour number on the dial. The codes 07 -> 5 and 08 ->10 are affected.
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 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.
Details
- Recall number
- Z-0089-2010
- Initiated
- September 21, 2009
- Posted by FDA
- October 29, 2009
- Terminated
- June 22, 2011
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 5,892 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.
- Recalling firm
- Ohio Medical Corporation, Gurnee, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0090-2010 | Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031…The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The… | 09/21/2009Terminated |