Z-0130-06

Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter...

Name: Z-0130-06 Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter...
Creator: Baxter Healthcare Corp.
Published: 2005-02-10
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-02-10 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015 on 2005-02-10. The reason FDA records is "Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0130-06
Status: Terminated
Initiated: 2005-02-10
Posted: 2005-11-16
Terminated: 2008-11-03
Recalling firm: Baxter Healthcare Corporation
Product: Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: FRN Pump, Infusion
Reason for recall: Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
FDA root cause: Other
Action: Baxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as soon as revised software and hardware is available, Baxter would modify the pumps at no additional charge to the consignee. Any questions were directed to their Baxter Medication Delivery Product Information Center at 1-800-933-0303.
Quantity in commerce: 24,009 pumps
Distribution: Nationwide including Puerto Rico, and internationally through Baxter subsidiaries in Canada, Chile, Hong Kong, Kuwait and Saudi Arabia.
Product codes and lots: product codes 2L3107 and 2L3107R, all serial numbers

Product code FRN

K993387Class IIIpump Pain Management System, Model 2L3107kBaxter Healthcare Corp / cleared 1999-11-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)