Who else makes this device?

Name: ALL-IN-ONE
Brand: ALL-IN-ONE

ALL-IN-ONE · Container, I.V. → General Hospital

7manufacturers in China registered for this device type

3catalogue numbers in this listing

8510(k) clearances naming this product code

10recalls on this code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Zhejiang (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 KPE
Manufacturer	City	Province	Registered as	Device types
Ming FAI Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	17
Yangzhou Xingwei Medical Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	5
Wanying Health & Technology (Zhongshan) Co., Ltd.	Zhongshan	Guangdong	Contract manufacturer	3
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Ming FAI Enterprise International Co., Ltd.	Kowloon	Hong Kong	Exporter	18
Yangzhou Weideli Trading Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	10
Beijing L&Z Medical Technology Development Co., Ltd.	Beijing	Beijing	Manufacturer	2

Record

Regulatory record for ALL-IN-ONE
Listed by	Baxter Healthcare Corporation, United States
FDA product code	KPE
Device type	Container, I.V.
Device class	Class 2
Regulation	21 CFR 880.5025
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2023-07-07 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number
Packaging	Case of 15, case of 20
Distribution end date	2022-09-14

Catalogue Numbers

Catalogue numbers for ALL-IN-ONE
Catalogue number	Size	Status
2B8134		Withdrawn
2B8114		Withdrawn
2B8124		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ChemoPlus	Cardinal Health	54
Secure®	Metrix Company, THE	46
EVA TPN Bags	Valmed SRL	45
ChemoPlus	Cardinal Health 200, LLC	44
Container, I.V.	Metrix Company, THE	27
EcoFLX™ Empty Mixing Container	Douglas Medical Products, Inc	22
Cormix	Metrix Company, THE	21
PiSA BioPharm	Pisa Biopharm Inc.	20
Pinnacle®	B. Braun Medical Inc.	20
Apex®	B. Braun Medical Inc.	18
Acta Medical	Acta Medical, LLC	17
McKesson	Mckesson Medical-Surgical Inc.	14

Showing 12 of 59. All products under Container, I.V.

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111217	2011-06-14
K090096	2009-01-30
K020485	2002-03-12
K983294	1998-11-03
K964853	1997-03-31
K945193	1995-05-12
K932477	1994-06-10
K922214	1993-03-26

Recalls

2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. 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
2018-09-12	Class II	Process control	Potential ability to leak once used for compounding.	158,163 units	2020-11-02
2018-09-12	Class II	Process control	Potential ability to leak once used for compounding.	281,350 units	2020-11-02
2018-09-12	Class II	Process control	Potential ability to leak once used for compounding.	110,134 units	2020-11-02
2018-09-12	Class II	Process control	Potential ability to leak once used for compounding.	136,800 units	2020-11-02
2018-09-12	Class II	Process control	Potential ability to leak once used for compounding.	456,071 units	2020-11-02
2017-07-27	Class II	Process control	A leak may allow for microbial contamination of the sterile fluid path.	29,088 units	2020-11-03
2014-09-16	Class I	Equipment maintenance	Particulate matter found inside the fluid path.	94,224	2017-06-21
2014-09-16	Class I	Equipment maintenance	Particulate matter found inside the fluid path.	20448	2017-06-21
2010-02-15	Not classified	Nonconforming Material/Component	Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product.	64,560 units	2012-01-29
2010-02-15	Not classified	Nonconforming Material/Component	Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product.	79,308 units	2012-01-29

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.

ALL-IN-ONE