| Class 2 Device Recall Vacuum Collection Bottle | |
Date Initiated by Firm | September 21, 2009 |
Date Posted | October 29, 2009 |
Recall Status1 |
Terminated 3 on June 22, 2011 |
Recall Number | Z-0089-2010 |
Recall Event ID |
53192 |
Product Classification |
Bottle, collection, vacuum - Product Code KDQ
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Ohio Medical Corporation 1111 Lakeside Dr Gurnee IL 60031
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For Additional Information Contact | Ms. Anita Christ 800-448-0770 |
Manufacturer 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 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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