Alaris Syringe Pump, Model 8110. The firm name on the… recallZ-0322-2018 · CareFusion 303, Inc. · initiated Nov 17, 2017

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-0322-2018

Status

Terminated

Initiated by the company

Nov 17, 2017

Recalling firm

CareFusion 303, Inc.

Quantity

73,611

Product code

FRN

FDA submissions

K023264

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 Syringe Pump, Model 8110. 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.

Devices named in this recall

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

• Alaris 8100

  Carefusion 303, Inc. · Pump, infusion
  4 recalls78 deaths344,514 reports

Product lines

• BD Alaris Infusion SystemCarefusion 303, Inc. · 29 models · 1,242,913 reports · 16 recalls
• AlarisCarefusion 303, Inc. · 25 models · 1,236,345 reports · 16 recalls

Other devices under the same FDA submission

2 devices cleared under K023264 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Alaris 8110

  Carefusion 303, Inc. · Pump, infusion
  2 recalls4 deaths21,956 reports
• Alaris 8110

  Carefusion 303, Inc. · Pump, infusion
  2 recalls2 deaths15,547 reports

Other products in the same recall event

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

• Z-0323-2018 · Terminated
  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 s…