Who else makes this device?

Name: ICU Medical, Inc.
Brand: ICU Medical, Inc.

ICU Medical, Inc. · Set, I.V. Fluid Transfer → General Hospital

8manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Zhejiang (3), Jiangsu (3), Hong Kong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LHI
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Suzhou Jinsheng Plastic Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
Ming FAI Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	17
Gcmedica Enterprise Ltd.(Wuxi)	Wuxi	Jiangsu	Contract manufacturer	55
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Ming FAI Enterprise International Co., Ltd.	Kowloon	Hong Kong	Exporter	18
Zhejiang Medtec Medical devices Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	10
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	7

Record

Regulatory record for ICU Medical, Inc.
Listed by	ICU Medical, Inc, United States
FDA product code	LHI
Device type	Set, I.V. Fluid Transfer
Device class	Class 2
Regulation	21 CFR 880.5440
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K913804
Record published	2026-04-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Packaging	Case of 25, case of 30

Catalogue Numbers

Catalogue numbers for ICU Medical, Inc.
Catalogue number	Size	Status
PA01LL-XS		In distribution
PA01-XS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Kenaflexx	Kentron Healthcare, Inc.	49
Set, I.V. Fluid Transfer	Mps Medical, Inc.	27
Vial Adaptor	West Pharma. Services IL, Ltd.	26
Vial Adapter	West Pharma. Services IL, Ltd.	22
Extension SET	MPS Pharma & Medical, Inc.	19
Vial Adapter Medic’up	Union Plastic	17
Exactamix	Baxter Healthcare Corporation	16
Mix2Vial Transfer Device	West Pharma. Services IL, Ltd.	15
Arisure	Yukon Medical, LLC	13
ViaLok	Yukon Medical, LLC	12
ICU Medical	ICU Medical, Inc	12
Codan	Codan US Corp.	10

Showing 12 of 233. All products under Set, I.V. Fluid Transfer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243985	2025-01-22
K192154	2020-04-20

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of ICU Medical, Inc.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Excelsior Medical LLC	510(k) number	2014-06-05	Class II	Nonconforming Material/Component	There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.	4250 tubing sets (PA03 – 78 cases; BX03 – 92 cases (each cas	2015-08-19

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2008-03-24	Not classified	Packaging process control	Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a’ Y’ site.	350 units	2010-09-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

ICU Medical, Inc.