—#32797

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

FDA product code: NEP--
510(k) numbers: K955622
Affected lot / code info: 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

Why it was recalled

The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide and internationally through Baxter subsidiaries to the United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan and Korea.

Timeline

Recall initiated: 2004-04-26
Posted by FDA: 2004-07-20
Terminated: 2006-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #32797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.