The Central Drugs Standard Control Organization (CDSCO) has issued a medical device alert regarding a voluntary recall initiated by Cook India Medical Devices Private Ltd. for several products utilizing Beacon Tip technology.
The recall is due to an increase in reports of polymer degradation of the catheter tip, leading to potential tip fracture and/or separation.
Key Changes
The alert affects multiple product lines, including Beacon Tip Torcon NB Advantage Catheter, Beacon Tip Royal Flush Plus High-Flow Catheter, Beacon Tip Centimeter Sizing Catheters, Beacon Tip White Vessel Sizing Catheters, Beacon Tip Vessel Sizing Catheters, Shuttle Select Slip-Cath Slip-Cath, Beacon Tip Catheter, Haskal Transjugular Intrahepatic Portal Access Set, Liver Access and Biopsy Needle Set, Neff D'Agostino Percutaneous Access Set and Aprima TMAccessNonvascular Introducer Set. All lots of these products are subject to the recall.
The affected products were initially approved under Registration Certificate no MD-113 dated 09.06.2016 and Import License no MD113-1128 dated 14.06.2016, valid until 30.04.2019.
Medical directors, healthcare professionals, distributors, users, and staff involved in patient management are advised to take action.
Patients and healthcare professionals are instructed to report any adverse events suspected to be associated with the use of these products to the manufacturer, importer, and CDSCO.
Impact Analysis
Cook India Medical Devices Pvt. Ltd.
Continue to coordinate the voluntary recall process effectively.
CDSCO
Consider further regulatory actions if necessary to protect public health.
Healthcare Providers/Hospitals
Implement a communication strategy to inform patients about the recall and potential follow-up actions.
Distributors
Maintain detailed records of all recalled products and communications related to the recall.
Patients
Patients should report any adverse events to their healthcare provider and to Cook India Medical Devices Pvt. Ltd. and CDSCO.
Key Entities Referenced
Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for ensuring the safety, efficacy, and quality of these products.
Cook India Medical Devices Private Ltd.: The Indian agent/manufacturer of the recalled medical devices, responsible for initiating and managing the voluntary recall.
Cook Incorporated: The original manufacturer of the medical devices, located in the USA.
Registration Certificate no MD-113: The registration certificate issued by CDSCO for the affected medical devices.
Import License no MD113-1128: The import license issued by CDSCO for the affected medical devices.
Central Drugs Standard Control Organization
Directorate General of Health Services ,
Ministry of Health and Family Welfare
.I~
Government of India
(Medical Devices and Diagnostics Division)
Food & Drugs Administration Bhavan,
Kotla Road, New Delhi.
o
FileNo: 31-113-MD/2006-DC (Re. Reg.03) Date: 2 JUN 2017
MEDICAL DEVICE ALERT
DEVICE
The details of product are tabulated asbelow:
Lot
S.No. Product Brand Name Model No.
Number
Beacon" Tip Torcon NB®Advantage Catheter HNBRS.O All lots
I.
HNBR6.0
Beacon® Tip Royal Flush" Plus High-Flow HNRS.O All lots
2.
Catheter
• Beacon" Tip Centimeter Sizing Catheters, NRS.O All lots
3. • Beacon" Tip White Vessel Sizing Catheters,
• Beacon" Tip Vessel Sizing Catheters.
4. Shuttle" Select Slip-Cath SCBRS.S-/-SHTL All lots
5. Slip-Cath" Beacon" Tip Catheter SCBRS.O,SCBRS.5,SCBR6.5 All lots
Haskal Transjugular Intrahepatic Portal Access HTPS All lots
6.
Set
7. Liver Access and Biopsy Needle Set LABS-I00, LABS-200 All lots
8. Neff D'Agostino Percutaneous Access Set NPAS-100 All lots
9. Aprima TMAccessNonvascular Introducer Set NPAS-/-SST, NSSW-/-SST Air lots
BACKGROUND
The above mentioned products were approved by this office vide Registration Certificate no MD-l13
dated 09.06.2016 and Import License no MDl13-1128 dated 14.06.2016 valid upto 30.04.2019.
These products Registration Certificate and Import License were renewed based on the documents
submitted bythe Indian agent/manufacturer.
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The Indian agent M/s Cook India Medical Devices Private Ltd., has informed this office that the
manufacturer has initiated avoluntary recall for all products having Beacon" Tip technology.
PROBLEM
There is an increase in reports of Polymer degradation of the catheter tip, resulting in tip
fracture and/or separation.
ACTION BY
~ Medical Directors/Healthcare professionals
~ Distributors and the UsersI "
~ Staff involved in the management of patients.
ADVERSE EFFECTS
,
,
.,
Patients and Healthcare professionals are advised to report adverse events suspected to be
1
associated with the use of above mentioned products to the manufacturer, Importer and CDSCO.
CONTACTS
~ Central Drugs Standard Control Organization, Directorate General of Health Services,
Ministry of Health and Family Welfare, Government of India, FDABhavan, ITOKotla Road,
New Delhi-110002
Tel: 91-11-23236975/23236971
Fax:91-11-23236973
Email: dci@nic.in
~ M/s Cook India Medical Devices Pvt. Ltd., 4/249A, Rasim Enclave, Poonamallee High Road,
Gaparasanallur, Kattupakkam, Chennai - 600056
Tel: +91-44-2679 3000
Fax:+91-44-2679 1143
Email: pooja.gupta@cookmedical.com
~ M/s Cook Incorporated., 750 Daniels Way, Bloomington, IN47404-0489, USA.
Tel: +01-812-339-2235
Email: sutkowski.ed@cookmedical.com
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