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Alaris PCA Pump, Model 8120. The firm name on the label is… recallZ-0323-2018 · CareFusion 303, Inc. · initiated Nov 17, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 Center or email them to schedule service of the device at the BD Service Depot. Enclosed with the notification letter was a list of affected serial numbers, an excerpt from the user manual to "Prepare Syringe and Administration Set (Syringe Module)", and a customer response card to be returned via mail, email or FAX to confirm the notification has been received. For further questions, please call (858) 617-5977.

Recall details

Recall number
Z-0323-2018
Status
Terminated
Initiated by the company
Nov 17, 2017
Recalling firm
CareFusion 303, Inc.
Quantity
73,611
Product code
MEA
FDA submissions
K032233
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, Taiwan, and South Africa.

Product description

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 delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.

Code information (models, lots, serial numbers)

UDI 10885403812002. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 78588).

Sources and updates

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