Fisher & Paykel Healthcare, Ltd.

⚠️ Moderate Risk

FEI: 3002806988 • Auckland • NEW ZEALAND

FEI

FEI Number

3002806988

📍

Location

Auckland

🇳🇿

Country

NEW ZEALAND

🏢

Address

15 Maurice Paykel Place, East Tamaki, Auckland, , New Zealand

Moderate Risk

FDA Import Risk Assessment

37.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

5/16/2017

Latest Refusal

1/10/2005

Earliest Refusal

Score Breakdown

Violation Severity

55.9×40%

Refusal Volume

46.5×30%

Recency

0.0×20%

Frequency

13.8×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

50817×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

11810×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3417×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
5/16/2017	73BTLVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
5/16/2017	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/26/2013	73BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73BTLVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73CBPVALVE, NON-REBREATHING	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/22/2013	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/26/2005	73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/10/2005	79FXXMASK, SURGICAL	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Fisher & Paykel Healthcare, Ltd.'s FDA import refusal history?

Fisher & Paykel Healthcare, Ltd. (FEI: 3002806988) has 17 FDA import refusal record(s) in our database, spanning from 1/10/2005 to 5/16/2017.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Fisher & Paykel Healthcare, Ltd.'s FEI number is 3002806988.

What types of violations has Fisher & Paykel Healthcare, Ltd. received?

Fisher & Paykel Healthcare, Ltd. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Fisher & Paykel Healthcare, Ltd. come from?

All FDA import refusal data for Fisher & Paykel Healthcare, Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.