Recall Z-2205-2012— CareFusion 303, Inc.

Name: FDA recall Z-2205-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Class I · Terminated

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2012-06-15, terminated 2014-05-13. It names one FDA 510(k) clearance: K950419. Product: Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.. Reason: The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly.

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-06-15
Terminated: 2014-05-13
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSImed Corp.·cleared 1995-06-21

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 Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

Reason for recall

The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly

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