Recall Z-2362-2015— CareFusion 303, Inc.

Name: FDA recall Z-2362-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-21

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2015-07-21, terminated 2018-12-14. It names one FDA 510(k) clearance: K023264. Product: Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.. Reason: Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2015-07-21
Terminated: 2018-12-14
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110Alaris Medical Systems, Inc.·cleared 2002-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

Reason for recall

Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.

Data sourced from openFDA. This site is unofficial and independent of the FDA.