**Medical Device Alert Summary**
This alert, issued by the Central Drugs Standard Control Organization (CDSCO) on December 10, 2013, addresses a potential issue with specific lots of a medical device used to maintain anastomotic integrity. The alert was triggered by an increase in customer complaints, including 3 reports from India, and 51 globally. Architectural design differences were identified in the internal components of the ECRT6OT reload. In 2013, five adverse events were attributed to the ECR6O0T issue, resulting in this field action. Affected lot numbers include J4AY8Z, ECR60T, J4CC1F, J4CJ78, JK44CCMoS49Xw, K4C94W, KACCOL, and EKaCFSD. The alert is directed towards medical directors, healthcare professionals, distributors, users, and staff involved in patient management. Contact information for Johnson & Johnson Limited and the CDSCO is provided.
Key Entities Referenced
Central Drugs Standard Control Organization: Regulatory body under Directorate General of Health Services, Government of India.
Directorate General of Health Services: A government organization overseeing health services in India.
Medical Device Alert: A notification issued regarding potential safety issues with medical devices.
FDA Bhavan, Kotla Road, New Delhi: Location of Central Drugs Standard Control Organization
Johnson Johnson Limited: Manufacturer of medical devices, specifically mentioned in relation to complaints and issues.
Village Kalher, ThaneBhiwandi Road, Bhiwandi, Maharashtra: Location of Johnson and Johnson Limited
ECR60T: Specific product code of a medical device reload experiencing issues, leading to field action.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies and programs in India.
ii Central Drugs Standard Control Organization
Directorate General of Health Services
Government of India
(Medical Device Div Fi os oio dn &)
Drugs Administration Bhavan,
Kotla Road, New Dethi
Date: 10.12.2013
File No: 31-1054-MD/2011
MEDICAL DEVICE ALERT
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prevent a used reload from being refired.
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intervention to help achieve dnd maintain anastomotic integrity, |
—— SS
ate
Product Code ‘ Affected Lot “|
J4AY8Z
|
ECR60T J4CC1F / |
J4CJ78
JK44CCMoS49Xw
|
K4C94W
| KACCOL
—__EKaCFSD
Page 1of3» Medical directors/ Healthcare Professionals
> Distributors and Users.
> Staff involved in the management of patients
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In india 3 complaints were reported for the affected lots.. Globally the manufacturer has
received 51 customer complaints identified architectural design differences in the
internal components of the ECRT6OT reload. In 2013, there were 5 adverse events
attributed to ECR6O0T issue which yesulted in the escalation to field action.
Page 2 of 3= 2. Mls. Johnson & Johnson Limited, J-1 Shree Arihant Complex, Village
Kalher, Thane-Bhiwandi Road, Bhiwandi
Tel: 0124-4285855
Fax: 0124-4285855
E-mail: ksaini@its.jnj.com
3. Central Drugs Standard Control Organization, Directorate General of Health
Services, Ministry of Health and Family Welfare, Government of India, FDA
Bhavan, ITO, Kotla Road, New Delhi -110002
Tel: 91-11-23236975 / 23236971
Fax: 91-11-23236973
E-mail: dci@nb.nic.in,
Page 3 of 3