Inspecting the Alaris™ Pump Module Bezel
PN P00000360
DIR No.: 10000351665 Version: 00
Page 3 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Explanation
BD has initiated a recall expansion of the Alaris pump module to include all bezels
manufactured between April 2011 and June 2017. All of the bezels subject to this recall
expansion were manufactured with a specific type of plastic, called FR-110. BD’s ongoing
investigation has determined that the bezel manufacturing process for the FR-110 plastic
may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to
separation of the bezel post (recall issue) as well as other damage to the bezel (for
example, external cracking). The separation of one or more bezel posts is a potential safety
concern. Affected pumps have different levels of potential risk.
Until the bezels affected by this recall are replaced by BD or deemed unaffected in
accordance with this inspection procedure, customers should inspect bezels during their
annual preventive maintenance schedule. Any pumps with separated bezel posts should be
removed from service.
This service bulletin provides the instructions and pictures to assist with the bezel
inspection during the annual preventive maintenance schedule. After performing the
identification procedures below, any pump modules that are identified as unaffected by the
bezel recall do not require reinspection during their routine preventive maintenance.
NOTE:
The following pump modules are not affected by the bezel recall:
•
BD Alaris™ pump modules
•
Alaris pump modules manufactured after June 2017
•
Alaris pump modules serviced with bezel assembly kit P/N 49000270
•
Alaris pump modules that were manufactured prior to April 2011 and have not been serviced with
customer-ordered bezel assembly kits P/N 10964559 or P/N 49000204
