Z-2146-2011

Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery...

Name: Z-2146-2011 Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery...
Creator: Baxter Healthcare Corp.
Published: 2011-03-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-03-15 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield... on 2011-03-15. The reason FDA records is "Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2146-2011
Status: Terminated
Initiated: 2011-03-15
Posted: 2011-05-05
Terminated: 2012-03-12
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 3,696 units
Distribution: Worldwide Distribution - USA including AL and the countries of Mexico and Spain
Product codes and lots: product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054

Product code MEB

K982102Class IISingleday Infusor 2 Ml/hr (Elastomeric Infusion Device) Model, Infusor Sv 5 Ml/hr (Elastomeric Infusion Device) Model CyBaxter Healthcare Corp / cleared 1998-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)