The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Voluntary recall of the bbl™ mgit™ mycobacteria growth indicator tube (lot no. 3042467) due to a portion of tubes of the product contain an incorrect prefix on the barcode label. the incorrect prefix begins with "43 02" instead of the required "43 01". the instrument bactec™ mgit may report an incorrect result for growth and detection function.
Acción
- Do not use the BBL™ MGIT™ Mycobacteria Growth Indicator Tube (lot No. 3042467)
- Retum all unused product to the manufacturer.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Damage of the product (iv cannula) due to fire manufactured by mis wellmed international industries, pvt. ltd, a-176 & 177, sector -63, noida, up for export to bangladesh - reg.
Acción
Please refer to your letter dated 23.06.2014 on the subject cited above. In this connection, the inspection of the incident site was carried out by the officials of COSCO (EZ), Kolkata and State Licensing Authority (SLA), West Bengal.
The inspection team observed that material was found stored in damaged conditions and was without legible Batch No., Mfg. & Exp. Date details etc. Further, details of incidence could not be ascertained from Bongaon Municipality. The inspection team concluded that quality and quantity of the material and actual cause of incidence cannot be
ascertained.
In view of above, you are directed to destroy the material as per your SOP and
dispose off the material as per the provisions of Biomedical Waste Management Act and other applicable laws in presence of Drugs Inspector from SLA, WB in coordination with Bongaon Municipality.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Recall of "echelon endoscopic linear cutter reloads black (ecr60t)" due to the potential for incomplete staple line formation from reload damage during firing sequence which may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
There is an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.
Acción
The Indian agent M/s Cook India Medical Devices Private Ltd., has informed this office that the manufacturer has initiated a voluntary recall for all products having Beacon" Tip technology.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Lps is a limb preservation system. one of its component of the i.E lower extremity dovetail intercalary component has the potential for the fracture of the female component when exposed to certain physiological loads. this recall is only applied or this component and not the whole knee system.
Acción
- Safety Communication to Inform physicians and patients about the risk of catheter entrapment associated with the use of Onyx. - Specific Changes in the Information of Use to include addltional safety information
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
There has been a voluntary recall of the 2 lots of the bone cancellous bone screw because the length of the screw in the package does not match the length described on the package label.
Acción
- Cease Further Distribution or use of the affected product immediately - Communication to all the Surgeons, Health professionals, Distributors where these products have been transferred.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Voluntary field action for ht connect peripheral guidewires due to a small number of devices exhibiting partial delamination of the ptfe coating.
Acción
Abbott Vascular has ceased distribution of the product while evaluating appropriate corrective and preventive actions.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Recall of asr hip replacement implants due to increased rates of revision.
Acción
- Do not implant DePuy ASR hip replacements.
- Return all unused ASR hip replacement implants to the manufacturer.
- Inform all patients implanted with ASR hip replacements about this recall and
schedule them for a follow-up visit.
- Follow up all patients implanted with ASR hip replacements with clinical
examination at least annually.
- For patients presenting with symptoms of abnormal pain, limping, swelling
around the hip, deteriorating hip function or radiological abnormality:
* consider measuring cobalt and chromium ion levels in whole blood and/or
performing cross sectional imaging including MRI or ultrasound scan.
* If metal ion levels in whole blood are elevated above 120 nmol/L (cobalt)
or 135 nmol/L (chromium) [ie seven parts per billion (ppb) for either metal
ion], a second test should be performed three months after the first in
order to identify patients who require closer surveillance, which may
include cross sectional imaging.
* If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or
tissue masses then consider revision surgery.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Based on the three years clinical data analysis from absorb ii it has been observed that there is an over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.
Acción
The Indian agent M/s Abbott Healthcare Pvt. Ltd., has informed this office that the manufacturer has initiated a Field Safety Notice in European countries to communicate that product use will' be limited to established post-market registries to facilitate the collection of real-world evidence for Absorb BVSand Absorb GTl BVSsystems.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Recall of "onyx liquid embolic system" due to catheter entrapment, which could lead to breakage haemorrhage and possibly death.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
Voluntary recall has been initiated due to the reason that during injection of cement, (the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject the cement. this could result in surgical delay which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the another reason has been reported that , firm reported that the cement mixer used to prepare cement for surgery has been identified to not tum properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to addtiional anesthesia in another surgical procedure.
Acción
Johnson & Johnson has ceased distribution of the product while evaluating appropriate corrective and preventive actions.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
M/s baxter (india) pvt.Ltd.,plot no.70, a-26, rama road, industrial area, new delhi-110015 has imported the said product with a shelf life of 5 years; whereas approved shelf life is 3 years by cdsco.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
National institute of bilogicals, noida reported that the product sample is not of standard quality under drugs and cosmetics act 1940 and rules thereof in respect to the test for specificity, avidity/intensity, reactivity and titre.
Acción
Do not use the Combipack ABD, Anti-A, B & D Batch/Lot No: 116160303 • Return all unused product to the manufacturer.
The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
Notas adicionales en la data
Causa
National institute of biological, noida reported that the product sample is spurious and not of standard quality under drugs and cosmetics act 1940 and rules thereof in respect to the test for identification (anti-a (lg m) monoclonal & anti-b (lg m) monoclonal) , prozone and titre for (anti-d (lg m) monoclonal.
Acción
Do not use the Combipack ABO, Anti-A, B & D Batch/Lot No: 116160303 • Return all unused product to the manufacturer.