Z-0089-2010

Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number...

Name: Z-0089-2010 Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number...
Creator: Ohio Medical Corporation
Published: 2009-09-21
License: https://open.fda.gov/license/

Ohio Medical LLC / initiated 2009-09-21 / Terminated / root cause: manufacturing process

FDA source

Ohio Medical Corporation began a recall of 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... on 2009-09-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0089-2010
Status: Terminated
Initiated: 2009-09-21
Posted: 2009-10-29
Terminated: 2011-06-22
Recalling firm: Ohio Medical LLC
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.
Product code: KDQ Bottle, Collection, Vacuum
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and 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.

Product code KDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)