Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Dee

FDA device recall Z-1054-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

NEP

Quantity affected

500 devices

Distribution

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

Date initiated

2004-04-26

Date posted

2004-07-20

Date terminated

2006-04-11

Location

Round Lake, IL

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