Oakville, Canada
Canadian Hospital Specialties recalls
5 recalls recorded since 2018, most recently on 11 June 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 June 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2408-2024
- Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Terminated Class III Medical devices
- Recall started
- 19 August 2022
- Terminated
- 20 March 2023
- Reason
- 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.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0202-2023
- MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Terminated Class II Medical devices
- Recall started
- 16 July 2019
- Terminated
- 28 May 2025
- Reason
- The firm received a complaint that the connector detached from the feeding tube.
- Distribution
- GA and TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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) 8F
Terminated Class II Medical devices
- Recall started
- 1 December 2018
- Terminated
- 2 April 2021
- Reason
- 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.
- Distribution
- US in the states of TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 Fe
Terminated Class II Medical devices
- Recall started
- 11 June 2018
- Terminated
- 13 March 2019
- Reason
- The product may be packaged with the incorrect length of feeding tube as labeled.
- Distribution
- Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.