Recall Z-0323-2018 ยท MEA Pump, Infusion, Pca
CareFusion 303, Inc.
Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent deliv
| Date | Nov 17, 2017 |
| Status | Terminated |
| Reason | The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued "Medical Device Safety Notification, dated November 17, 2017, via UPS. The letter describes the potential issue, affected products, potential risks, and required action for the users. The actions noted that clinicians can continue to use the device and follow the Alaris System User Manual for proper loading of the syringe. Per the manual, clinicians should ensure the plunger grippers lock and hold the syringe plunger in place. The Biomedical Engineering can detect if the device has this issue and if the issue described occurs, the user is to contact BD Support |
| Quantity | 73,611 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032233 | MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc., Sep 9, 2003 |