Data / Medical devices / Canada / Canadian Hospital Specialties Ltd.

Canadian Hospital Specialties Ltd.: FDA-registered device maker in OAKVILLE Ontario, Canada, 16 510(k) clearances

Name: Canadian Hospital Specialties Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Canadian Hospital Specialties Ltd. is registered with the FDA (registration 8022210) in OAKVILLE Ontario, Canada. It lists 32 device types. The FDA files 16 510(k) clearances under its listings, the newest dated June 3, 2014. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 8022210
FEI number: 3932
Address: 2760 Brighton RD., OAKVILLE Ontario, Canada, L6H 5T4
Owner or operator: Canadian Hospital Specialties Ltd. (8022211)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: April 24, 2002
Registered through: 2027
Brand names listed: Anesthesia Kit, Anesthesia kit, CONNECTING TUBE, CT Angiographic syringe, General surgery tray, MED-RX HYDROPHOBIC INSUFFLA, MED-RX PATIENT DELIVERY SET, MED-RX Pediatric Feeding Tube and Accessories and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Specification developer	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Contract manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Contract manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Epidural Anesthesia Kit	OGE	2	Contract manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Contract manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Introducer, Syringe Needle	KZH	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Manufacturer	accessdata.fda.gov
Nerve Block Tray	OGJ	2	Contract manufacturer	accessdata.fda.gov
Protector, Hearing (Circumaural)	EWE	U	Manufacturer, Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Spinal Anesthesia Kit	OFU	2	Contract manufacturer	accessdata.fda.gov
Spinal Epidural Anesthesia Kit	OFT	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
Suture Removal Kit	MCZ	1	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Manufacturer	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Manufacturer	accessdata.fda.gov
Tube, Feeding	FPD	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 3, 2014	K131183	MED-RX ORAL/ENTERAL SYRINGE	KNT	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
June 28, 2012	K120375	MED-RX PATIENT DELIVERY SET	FPA	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
December 23, 2011	K112799	MED-RX EXTENSION SET WITH T-CONNECTOR	FPA	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
December 13, 2010	K100700	MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES	FPD	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
November 8, 2010	K102073	MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS	FPA	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
November 5, 2007	K071875	V-CATH POLY PICC	LJS	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
April 22, 2004	K032981	SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09	BSP	Substantially Equivalent	Invamed Technologies, Inc.	accessdata.fda.gov
September 20, 2002	K022099	SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S	FOZ	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
November 28, 2001	K010607	MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001	LJH	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
October 13, 2000	K994059	CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07	CAZ	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
August 25, 1999	K990777	MED-RX EXTENSION SETS	FPA	Substantially Equivalent	Benlan, Inc.	accessdata.fda.gov
November 23, 1998	K983916	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)	FOZ	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
April 30, 1996	K953300	V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER	LJS	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
June 23, 1995	K951384	V-CATH PERCUTANEOUS INTRODUCER KIT	KZH	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
January 20, 1995	K945473	V-CATH BREAKAWAY NEEDLE INTRODUCER	KZH	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov
July 7, 1983	K831715	NEUROTRAC	ETN	Substantially Equivalent	Hdc Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 11, 2024	94834	Class II	Ongoing	Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator	A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.	accessdata.fda.gov
August 19, 2022	90926	Class III	Terminated	MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001	Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.	accessdata.fda.gov
July 16, 2019	83374	Class II	Terminated	MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36"	The firm received a complaint that the connector detached from the feeding tube.	accessdata.fda.gov
December 1, 2018	81763	Class II	Terminated	MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding	The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.	accessdata.fda.gov
June 11, 2018	80374	Class II	Terminated	MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, C	The product may be packaged with the incorrect length of feeding tube as labeled.	accessdata.fda.gov
December 11, 2015	72851	Class II	Terminated	MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada	The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.	accessdata.fda.gov
December 12, 2011	60828	Not yet classified	Terminated	Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.	The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.	accessdata.fda.gov

Compare with other makers

Updated July 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.