Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital

FDA device recall Z-0156-2013 · posted 2012-10-25 · Terminated

Recall details

Recalling firm

Baxa Corporation

Reason for recall

The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use.

Action taken

Baxa Corporation sent a "REPEATER PUMP PRODUCT NOTICE" to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received a CD containing a copy of the correct Operator Mannual, 5300-0754. Contact Technical Support at 800-678-2292 for questions regarding this notice.

Root cause

Packaging process control

Status

Terminated

Product code

NEP

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.

Date initiated

2012-10-03

Date posted

2012-10-25

Date terminated

2013-02-15

Location

Englewood, CO