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Welch Allyn, Inc.

United States·US-MF-000013394

Last updated September 17, 2026

Information

Country: United States
Address: 4341, State Street Road, Skaneateles Falls, New York, United States
Website: www.baxter.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 484-949-1130
PRRC Contact: —
EUDAMED SRN: US-MF-000013394
FDA FEI Number: 1316463
DUNS Number: 198227881

Catalogue (5348)

Page 1 of 107

Device	Model / Reference	Registries	Class	Status
H3+ Patient Cable	9293-037-60	EUDAMED	Class I	Active
H3+ Patient Cable	9293-037-50	EUDAMED	Class I	Active
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901115	FDA UDI	Class II	Active
Welch Allyn, Inc.	901130	FDA UDI	Class II	Active
Welch Allyn, Inc.	901078	FDA UDI	Class II	Unknown
Welch Allyn, Inc.	901137	FDA UDI	Class II	Active
Welch Allyn, Inc.	901129	FDA UDI	Class II	Active
Welch Allyn, Inc.	901110	FDA UDI	Class I	Active
Welch Allyn, Inc.	901035	FDA UDI	Class II	Active
Welch Allyn, Inc.	901110	FDA UDI	Class I	Active
Welch Allyn, Inc.	901137	FDA UDI	Class II	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901136	FDA UDI	Class I	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901026	FDA UDI	Class II	Active
Welch Allyn, Inc.	901006	FDA UDI	Class II	Active
Welch Allyn, Inc.	901081	FDA UDI	Class I	Unknown
Welch Allyn, Inc.	901087	FDA UDI	Class I	Unknown
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901138	FDA UDI	Class II	Active
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901028	FDA UDI	Class II	Active
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901026	FDA UDI	Class I	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901043	FDA UDI	Class II	Active
Welch Allyn, Inc.	901138	FDA UDI	Class II	Active
Welch Allyn, Inc.	901071	FDA UDI	Class II	Active
Welch Allyn, Inc.	901065	FDA UDI	Class II	Active
Welch Allyn, Inc.	901001	FDA UDI	Class II	Active
Welch Allyn, Inc.	901026	FDA UDI	Class I	Active
Welch Allyn, Inc.	901055	FDA UDI	Class II	Unknown
Welch Allyn, Inc.	901129	FDA UDI	Class II	Active
Welch Allyn, Inc.	901007	FDA UDI	Class II	Active
Welch Allyn, Inc.	901128	FDA UDI	Class II	Active
Welch Allyn, Inc.	901026	FDA UDI	Class II	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901132	FDA UDI	Class II	Active
Welch Allyn, Inc.	901060	FDA UDI	Class II	Active
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901130	FDA UDI	Class II	Active
Welch Allyn, Inc.	901044	FDA UDI	Class II	Active
Welch Allyn, Inc.	901189	FDA UDI	Class II	Active
Welch Allyn, Inc.	901130	FDA UDI	Class II	Active
Welch Allyn, Inc.	901132	FDA UDI	Class II	Active
Welch Allyn, Inc.	901144	FDA UDI	Class II	Active
Welch Allyn, Inc.	901142	FDA UDI	Class II	Active

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Authorised Representatives

Welch Allyn Limited IE

Importers

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Authorities

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FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 20, 2021	Z-2482-2021	—	open, classified	If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
Apr 22, 2021	Z-1672-2021	—	terminated	Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Apr 22, 2021	Z-1673-2021	—	terminated	Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Feb 27, 2017	Z-1777-2017	—	terminated	A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
Oct 2, 2015	Z-0169-2016	—	terminated	The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard.
Mar 1, 2004	Z-0748-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0752-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-753-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0749-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0751-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0755-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0756-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0754-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0750-04	—	terminated	GMP deficiencies
Mar 1, 2004	Z-0757-04	—	terminated	GMP deficiencies
Dec 30, 2003	Z-0354-04	—	terminated	Mechanical setting errors that result in calibration errors.
Oct 27, 2003	Z-0244-04	—	terminated	Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.