Facility

CARE ESSENTIALS PTY LTD

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011059079
Establishment type	Manufacture Medical Device
Location	103 Mornington Street North Geelong Victoria, AU 3215
Registration status	Active · expires 2026
Parent company	CARE ESSENTIALS PTY LTD (owner-operator 10048196)
Brand names	Sterile Cocoon Convective Warming System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

System, Thermal Regulating
Product code DWJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5900

Recalls & enforcement

Class IITerminated2020-01-07
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

FDA inspections (1)

VAI2017-02-02
Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CARE ESSENTIALS PTY LTD (FEI 3011059079) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011059079-care-essentials-pty-ltd/

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