Baxter Lock Box for 250 mL Container, for use with 6060 Pump Family; Baxter product code 2L9363 and previously marketed

FDA device recall Z-1570-05 · posted 2005-04-22 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FRN

Quantity affected

846 units

Distribution

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

Date initiated

2004-09-01

Date posted

2005-04-22

Date terminated

2006-07-21

Location

Round Lake, IL

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