Baxter Healthcare Corp.: 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

Recall number

Z-1054-04

Recalling firm

Baxter Healthcare Corp.

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

Status

Terminated

Initiated

2004-04-26

Posted

2004-07-20

Terminated

2006-04-11

Reason

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

Root 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

500 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K955622"]

PMA numbers

not on file

Product code

NEP--

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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