Class 2 Device Recall Clintec Micromix Compounder

• Date Initiated by Firm: April 26, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 11, 2006
• Recall Number: Z-1054-04
• Recall Event ID: 28921
• 510(K)Number: K955622
• Product Classification: unknown device name - Product Code NEP--
• Product: Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy
• Code Information: product codes 2M8290 and 2M8290L, all serial numbers The recall extension concerns those units that had not been returned as of 2/16/05: serial numbes 10025, 11163, 11263, 11298, 11254, 11280, 10075, 11279, 11265, 11264, 10065, 11251, 11065, T12054, 10051
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted
• FDA Determined Cause: Other
• Action: Baxter began telephoning their customers on 4/26/04, advising them that an improperly adjusted Vlier pin could result in an ingredient delivery outside of stated accuracy limits. The accounts were requested to immediately stop using the Micromix Compounder and return the device to Baxter, and to evaluate all TPN formualtions that have been compounded but not administered to determine if any ingredients were delivered at a programmed volume of less than 1 mL. The account was advised to discard those solutions and recompound them using manual techniques. Follow-up recall letters were faxed to the accounts on the same date, reiterating the telephone calls. Baxter sent second recall letters dated 2/16/05 to the 15 customers who had not yet returned their Micromix Compounder as of 2/16/05, along with a copy of the 4/26/04 recall letter. The customers were informed of the new issue with the Micromix Compounder not recognizing decimal points for delivery volumes below 1 mL, and were again requested to return the Micromix Compounder and the handheld keypad to Baxter so that they may be corrected when the Micromix is reintroduced the market.
• Quantity in Commerce: 500 devices
• Distribution: Nationwide and internationally through Baxter subsidiaries to the United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan and Korea.

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.

• 510(K) Database: 510(K)s with Product Code = NEP-- and Original Applicant = BAXTER HEALTHCARE CORP.