Jackson-Pratt

Surgical Drain Perforated/Round 19Fr Silicone Center Perforation

Registry build 21.09.26
24manufacturers in China registered for this device type
47catalogue numbers in this listing
40recalls on this code

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GBX
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Zhejiang Baite Medical Appliances Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65

Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation

Record

Regulatory record for Jackson-Pratt
Listed by Cardinal Health 200, LLC, United States
FDA product code GBX
Device type Catheter, Irrigation
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-06-11
Record revised 2025-06-30 (version 4)

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
Packaging Box of 10, case of 8
Distribution end date 2025-06-30

Catalogue Numbers

Catalogue numbers for Jackson-Pratt
Catalogue number Size Status
SU130-1521 In distribution
JP-2216 In distribution
SU130-1327 In distribution
SU130-1328 In distribution
JP-2217 In distribution
SU130-1521 In distribution
JP-2189 In distribution
JP-2187 In distribution
SU130-1329 In distribution
JP-2210 In distribution
JP-2186 In distribution
JP-2292 In distribution
JP-2190 In distribution
SU130-1328 In distribution
JP-2191 In distribution
SU130-1327 In distribution
JP-2211 In distribution
JP-2290 In distribution
JP-2215 In distribution
JP-2221 In distribution
JP-2223 In distribution
JP-2212 In distribution
JP-2233 In distribution
JP-2214 In distribution
SU130-1329 In distribution
JP-2188 In distribution
JP-2232 In distribution
JP-2225 In distribution
JP-2221 Withdrawn
JP-2190 Withdrawn
JP-2211 Withdrawn
JP-2214 Withdrawn
JP-2223 Withdrawn
JP-2232 Withdrawn
JP-2188 Withdrawn
JP-2189 Withdrawn
JP-2216 Withdrawn
JP-2217 Withdrawn
JP-2290 Withdrawn
JP-2233 Withdrawn
JP-2210 Withdrawn
JP-2215 Withdrawn
JP-2292 Withdrawn
JP-2225 Withdrawn
JP-2187 Withdrawn
JP-2212 Withdrawn
JP-2191 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
One-Step™ Merit Medical Systems, Inc. 167
Cardinal Health Cardinal Health 200, LLC 109
Cook Cook Incorporated 85
ReSolve® Merit Medical Systems, Inc. 68
Pleur-Evac Teleflex Medical LLC 66
Total Abscession AngioDynamics, Inc. 36
Channel Drain C.R. Bard, Inc. 36
ReSolve Mini™ Merit Medical Systems, Inc. 32
Silicone Tubing, Radiopaque Bentec Medical OpCo, LLC. 25
Blake Ethicon, Inc. 19
Silicone Tubing, Translucent Bentec Medical OpCo, LLC. 19
Thoracentesis and Paracentesis Set Merit Medical Systems, Inc. 17

Showing 12 of 223. All products under Catheter, Irrigation

Recalls Naming This Product

19 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Jackson-Pratt
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 4111 devices
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 2480 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 921 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 3507
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 3520 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 0
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 1768 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 892 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 3550 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 812 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 0
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 750 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 179 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 2259 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 4112 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 4372 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 1920 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 5680 units
Cardinal Health 200, LLC UDI-DI 2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 0

Recalls

21 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 Closed
2024-03-27 Class II Under Investigation by firm Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. 202 cases of 12
2024-03-27 Class II Under Investigation by firm Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. 2905 cases of 12
2024-03-27 Class II Under Investigation by firm Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. 128 cases of 12
2024-03-27 Class II Under Investigation by firm Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. 64 cases of 6
2024-03-27 Class II Under Investigation by firm Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. 98 cases of 12
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 29515 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 8563 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 24963 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 220 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 2277 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 1150 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 22847 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 15493 units
2022-12-14 Class II Unknown/Undetermined by firm Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of 7129 units
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17
2018-06-11 Class II Device Design The suction valve may not close properly which could cause continuous suction. A total of 63,020 valves were distributed. Specific product 2020-08-17

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer