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 specific products utilizing Beacon Tip technology due to reports of polymer degradation of the catheter tip, potentially leading to fracture or separation.
Key Changes
The alert pertains to several 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 affected.
The recall is due to an increase in reports of polymer degradation of the catheter tip, which may result in tip fracture and/or separation.
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 advised to report any adverse events suspected to be associated with the use of these products to the manufacturer, importer, and CDSCO.
Action Items: Review inventory, identify and quarantine affected products, notify relevant staff, implement alternative devices, and report any adverse events to the manufacturer, importer and CDSCO.
Distributors
Action Items: Notify customers about the recall, arrange for the return of affected products, and coordinate with the manufacturer for replacements or refunds.
Patients
Action Items: Contact their healthcare provider if they have concerns or experience any adverse symptoms following a procedure involving these devices. Report any adverse events to their healthcare provider, the manufacturer, importer and CDSCO.
Cook India Medical Devices Private Ltd. and Cook Incorporated
Action Items: Continue managing the recall process, investigate the root cause of the polymer degradation, implement corrective actions, and communicate transparently with stakeholders.
CDSCO
Action Items: Monitor the recall process, investigate the incident, and take appropriate regulatory action.
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 that initiated the voluntary recall of the affected products.
Cook Incorporated: The original manufacturer of the affected products, located in the USA.
Registration Certificate no MD-113: The registration certificate issued by CDSCO for the affected products, dated 09.06.2016.
Import License no MD113-1128: The import license issued by CDSCO for the affected products, dated 14.06.2016, valid until 30.04.2019.
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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