Z-1569-05

Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and...

Name: Z-1569-05 Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and...
Creator: Baxter Healthcare Corp.
Published: 2004-09-01
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2004-09-01 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code... on 2004-09-01. The reason FDA records is "The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1569-05
Status: Terminated
Initiated: 2004-09-01
Posted: 2005-04-22
Terminated: 2006-07-21
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015
Product code: FRN Pump, Infusion
Reason for recall: The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
FDA root cause: Other
Action: Urgent Device Correction letters dated 9/1/04 were sent to all U.S. Baxter affected customers on the same date, to the attention of the Director of Nursing. The facilities were advised of the free-flow incident and as a result that Baxter wanted to heighten awareness of the proper clinical procedures for loading the sets into the infusion systems using these Lock Boxes with the 6060 Multi-Therapy Pump. Baxter''s investigation into the event confirmed that the 6060 pump door was left open after the lock box was attached to the pump. Baxter provided copie of the instructions for use of the lock box and pages from the 6060 pump operator''s manual which outline the proper procedure for loading the sets into the the pump and the pump into the lock box. The accounts were requested to complete and fax back to Baxter the enclosed response form, erifying receipt of the letter, confirming that the information has been provided to all users of the infusion system, and allowing Baxter to order and ship labels for the lock box and revised instructions for use to the facility. Any questions were directed to 1-800-843-78867.
Quantity in commerce: 640 units
Distribution: Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom.
Product codes and lots: all lot numbers/serial numbers of product codes 2L9354 and 606194

Product code FRN

K002679Class II6060 Multi-Therapy Pump, Model 2M9832; 6060 Epidural Pump, Model 2L9351Baxter Healthcare Corp / cleared 2000-09-18

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)