FDA alerts to Class I recall of Care Plus, Care Plus Models 1000-4000 and Lullaby Incubators due to risk of major injuries, death

The FDA is warning consumers that a corrective recall of Wipro GE Healthcare Private Ltd. Care Plus and Lullaby Incubators has been identified as Class I, the most serious type, because use of the devices has been found to pose a risk of serious injuries or death.

Initiated by the company on December 26, 2023, the recall covers a collective 15,138 Care Plus and Lullaby devices that were distributed between January 1, 1988 and December 31, 2015, and between January 1, 2008 and December 31, 2021, respectively.

Indicated to support a heated and humidified environment “within an enclosed bed compartment,” the Wipro GE Healthcare Private Ltd. Care Plus and Lullaby Incubators are critical for newborns who rely on body temperature regulation.

As can be referenced in the FDA announcement, the following products and their corresponding codes, model numbers, and manufacturing dates are affected:

  • Product Names: Care Plus, Care Plus Models 1000 through 4000 and Lullaby Incubator, Lullaby Incubator XP and Lullaby Incubator TR
  • Product Codes: FMZ
  • Model Numbers:
    • All models of Care Plus Hood Field Replacement Unit (FRU) kit: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
    • Care Plus Hood Door FRU kit: 6600-0082-850, 6600-0504-800, 6600-0148-800, 6600-0970-500 M1166822
    • All models of Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator
    • Lullaby Incubator Model Hood FRU kit: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 and
    • Lullaby Incubator Model Hood Door FRU kit: M1169767, M1160674, M1187512, M1206646
  • Manufacturing Dates:
    • Care Plus, Care Plus models 1000 through 4000: January 1, 1988, to December 31, 2015
    • Lullaby Incubator, Lullaby Incubator XP, Lullaby Incubator TR: January 1, 2008, to December 31, 2012

According to officials, the Care Plus and Lullaby Incubators are being recalled because while the bedside panel/porthole may appear closed, there are no guarantees that it is latched correctly. Other situations apply: The placement of a canopy cover may create the appearance of the bedside panel being secured and in a closed position, but the panel latches may not be correctly locked. Similarly, the panel can detach and open, leaving a patient vulnerable to falling if a bedside panel or porthole is not properly latched.

Use of an affected incubator have been found to present the following risks:

  • falls from the incubator because of improper door closure
  • injuries like “skin abrasions, bleeding, fractures, and head trauma.”

To date, Wipro GE Healthcare Private Ltd. has received a single report of major injury in connection to the now-recalled device. Beyond that report, no other related injuries or deaths have been reported.

The company issued an Urgent Medical Device Correction letter to all impacted customers on December 26, 2023, with the following recommendations for continued use of the device:

  • Ensure the latches are secure every time the bedside panel is closed
  • Manually check the porthole latches to ensure the porthole door latches are secure, every time the porthole doors are closed.
  • Ensure the porthole door is pulled so that it is latched every time the bedside panel and porthole is closed.

Questions and/or concerns about the U.S. recall may be directed to Wipro GE Healthcare Private Ltd. via 1-800-437-1171.

The FDA encourages healthcare professionals and consumers to report related adverse experiences or issues to its MedWatch program.


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