—#34844

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002679
Affected lot / code info: all lot numbers/serial numbers of product codes 2L9354 and 606194

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom.

Timeline

Recall initiated: 2004-09-01
Posted by FDA: 2005-04-22
Terminated: 2006-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34844. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.