Facility

Geelong Healthcare Manufacturing 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)	3034393266
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	AV-27 GIDC Sanand II, BOL Sanand, Ahmedabad Gujarat, IN 38217
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)

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.

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. “Geelong Healthcare Manufacturing Pvt Ltd (FEI 3034393266) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3034393266-geelong-healthcare-manufacturing-pvt-ltd/

Not open yet

Alerts for Geelong Healthcare Manufacturing Pvt Ltd

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.