Canadian Hospital Specialties Ltd.
MISSISSAUGA Ontario, CA
Canadian Hospital Specialties Ltd. appears in FDA device records in MISSISSAUGA Ontario, CA. FDA records list 7 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Canadian Hospital Specialties Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Benlan, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Canadian Hospital Specialties Ltd. between 1999 and 2014. The busiest year on record is 2010, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2001 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131183 | MED-RX ORAL/ENTERAL SYRINGE | KNT | Substantially Equivalent | |
| K120375 | MED-RX PATIENT DELIVERY SET | FPA | Substantially Equivalent | |
| K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | FPA | Substantially Equivalent | |
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | FPD | Substantially Equivalent | |
| K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | FPA | Substantially Equivalent | |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | LJH | Substantially Equivalent | |
| K990777 | MED-RX EXTENSION SETS | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003627840 | 3003627840 | CANADIAN HOSPITAL SPECIALTIES LTD | 1213 International Blvd., Burlington Ontario L7L 6W1 CA | 2026 | and 7 more, listed in full below |
| 3000153466 | 3000153466 | Canadian Hospital Specialties Ltd. | 215 EXPORT BLVD., MISSISSAUGA Ontario L5S 1Y4 CA | 2026 | |
| 8022210 | 3932 | Canadian Hospital Specialties Ltd. | 2760 BRIGHTON RD., OAKVILLE Ontario L6H 5T4 CA | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- FNYBasin, Emesis
- KTCBath, Sitz, Nonpowered
- FOBBedpan
- KDQBottle, Collection, Vacuum
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KYWContainer, Liquid Medication, Graduated
- NNIContainer, Specimen, Non-Sterile
- KYXDispenser, Liquid Medication
- OGEEpidural Anesthesia Kit
- HTDForceps
- LROGeneral Surgery Tray
- DXTInjector And Syringe, Angiographic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- KGBMask, Oxygen, Non-Rebreathing
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- OGJNerve Block Tray
- EWEProtector, Hearing (Circumaural)
- FPASet, Administration, Intravascular
- OFUSpinal Anesthesia Kit
- OFTSpinal Epidural Anesthesia Kit
- MCZSuture Removal Kit
- KYZSyringe, Irrigating (Non Dental)
- LJHSystem, Irrigation, Urological
- BYZTrap, Sterile Specimen
- BYYTube, Aspirating, Flexible, Connecting
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2408-2024 | 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. | Class II | Open, Classified | |
| Z-0202-2023 | 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. | Class III | Terminated | |
| Z-2281-2019 | 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" (91cm), REF 54-3680R | The firm received a complaint that the connector detached from the feeding tube. | Class II | Terminated | |
| Z-0725-2019 | 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 Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. | 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. | Class II | Terminated | |
| Z-2440-2018 | 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, Canada. | The product may be packaged with the incorrect length of feeding tube as labeled. | Class II | Terminated | |
| Z-0595-2016 | 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. | Class II | Terminated | |
| Z-1070-2012 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain