Who else makes this device?

Name: Wolf-PAK Self Safe IV Catheter
Brand: Wolf-PAK Self Safe IV Catheter

Wolf-PAK Self Safe IV Catheter · Catheter, Intravascular, Therapeutic, Short-Term Less than 30 Days → General Hospital

12manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

11recalls on this code

Who Else Makes It

Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FOZ
Manufacturer	City	Province	Registered as	Device types
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22
Bioxin Medical Co., Ltd.	Weihai	Shandong	Contract manufacturer	8
Weihai Jierui Medical Products Co., Ltd.	Weihai	Shandong	Contract manufacturer	3
Becton Dickinson Medical Devices Co., Ltd. Suzhou	Suzhou	Jiangsu	Contract manufacturer	2
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Zhejiang Kindly Medical Devices Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	16
Terumo Medical Products (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Shandong Ande Healthcare Apparatus Co., Ltd.	Zibo	Shandong	Manufacturer	7
Jiangxi Sanxin Medtec Co., Ltd.	Nanchang	Jiangxi	Manufacturer	6
Haolang Technology (Foshan) Limited Corporation	Foshan	Guangdong	Contract manufacturer	6
Guangdong Baihe Medical Technology Co., Ltd.	Foshan	Guangdong	Contract manufacturer	4
Foshan Special Medical Co., Ltd.	Foshan	Guangdong	Manufacturer	3

Record

Regulatory record for Wolf-PAK Self Safe IV Catheter
Listed by	Delta Med SpA, Italy
FDA product code	FOZ
Device type	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class	Class 2
Regulation	21 CFR 880.5200
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2020-04-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Case of 50, box of 4
Sizes	Length 25 mm; outer diameter 1 mm

Catalogue Numbers

Catalogue numbers for Wolf-PAK Self Safe IV Catheter
Catalogue number	Size	Status
3738760	Length 25 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arrow	Teleflex Medical LLC	2,368
Cook	Cook Incorporated	250
Cook Spectrum	Cook Incorporated	225
Jelco	ICU Medical, Inc	104
Medline	Medline Industries, Inc.	95
Deltaven Fast Flash	Delta Med SpA	77
Deltaven	Delta Med SpA	73
PowerGlide Pro	Bard Access Systems, Inc.	63
Peripheral Catheter Insertion Kit	Bard Access Systems, Inc.	62
Able Central Venous Catheter	Guangdong Baihe Medical Technology Co., Ltd.	62
Curaplex	Bound Tree Medical, LLC	61
BD Cathena™ Safety IV Catheter	Becton, Dickinson AND Company	59

Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200373	2020-08-26
K171530	2017-12-21
K121007	2012-12-28

Recalls

11 of these are Class II. 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
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	20,000 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	30,900 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	14,000 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	203,680 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	40,000 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	1400 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	229,320 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	5000 units
2021-06-21	Class II	Process control	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	10,000 units

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.

Wolf-PAK Self Safe IV Catheter