The Recall Desk
SevereFDA (Devices)·Z-2910-2020·Announced 2020-09-16

CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled

CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that delays or interruptions in life-sustaining infusions can cause serious injury or death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or death risk.

Plain-English summary

CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits, including specific assembly part numbers such as TC10008389, TC10010217, TC10012515, TC10013702, and TC10013664. The recall covers 28,346 units manufactured from April 07, 2017, to the present. These kits were distributed across all 50 U.S. states, the District of Columbia, and various international locations.

The recall is due to a risk that the pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress. This malfunction can result in a delay to the start of infusion, an interruption of infusion, or an inability to titrate medication. For high-risk patient populations receiving life-sustaining infusions, such delays or interruptions can cause serious injury or death.

Healthcare facilities and users should contact CareFusion 303, Inc. for instructions on how to address the affected units. The source text does not specify a particular consumer action for individual patients, but the risk is noted for high-risk patient populations.

The recalled product

Product
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump Components
Hazard
Affected units
28,346

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All kits manufactured from April 07
  • 2017 to Present.

Distribution

Distributed in 52 states:

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · fluid ingress

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