Facility

CARE ESSENTIALS INTERNATIONAL PVT LTD.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3012315097
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Naman Estate, Building No. 2, Survey No 527 & 528 Ahmedabad Gujarat, IN 38221
Registration status	Active · expires 2026
Parent company	CARE ESSENTIALS PTY LTD (owner-operator 10048196)
Brand names	CareGUARD Sterilization Wrap

Activity by year

Recalls (1)

Devices registered here (1)

Wrap, Sterilization
Product code FRG (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6850

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.

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 INTERNATIONAL PVT LTD. (FEI 3012315097) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012315097-care-essentials-international-pvt-ltd/

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