Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-20

FDA device recall Z-0090-2010 · posted 2009-10-29 · Terminated

Recall details

Recalling firm

Ohio Medical Corporation

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.

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.

Root cause

Process control

Status

Terminated

Product code

KDQ

Quantity affected

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, P

Date initiated

2009-09-21

Date posted

2009-10-29

Date terminated

2011-06-22

Location

Gurnee, IL