U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intravascular administration set - Product Code FPA
Causa
Sterility may be compromised.
Acción
The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately.
Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager.
If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intravascular administration set - Product Code FPA
Causa
Sterility may be compromised.
Acción
The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately.
Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager.
If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intravascular administration set - Product Code FPA
Causa
Sterility may be compromised.
Acción
The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately.
Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager.
If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Injector and syringe, angiographic - Product Code DXT
Causa
A report was received from a japanese distributor regarding a complaint from a hospital customer stating that ten packages of handi fil were not sealed.
Acción
Covidien send an Urgent Device Recall letter dated February 1, 2010, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and discontinue use of the product immediately. Customers were asked to complete the attached business form and report the quantity of affected product currently in their stock. Once the form is completed customers should fax the form to 314-654-8206. Once the business notification form is received, an RGA number will be sent to the customer for return of the product. Customers will receive credit for all returned product. For questions regarding this recall call the Product Monitoring Department at 800-778-7898. For questions about credit for the product, please call Customer Service at 888-774-1414, menu option 1, then menu option 2.
For questions regarding this recall call 513-948-5719.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
The tips of the drivers are breaking while being used to drive the screws into patients.
Acción
The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall.
Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
The tips of the drivers are breaking while being used to drive the screws into patients.
Acción
The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall.
Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The recall was initiated because beckman coulter has confirmed customer reports that different results have been obtained using
the same patient samples on access/access 2 and unicel dxl platforms. values obtained with
unicel dxl systems have been demonstrated to have a positive bias compared to values
obtained with access or access 2 systems.
Acción
An "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM.
If consignees need assistance or have any questions regarding the notification, they were instructed to contact Technical
Support at 1-800-854-3633 in the United States and Canada.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lamp, surgical - Product Code FTD
Causa
Premature bulb failure.
Acción
STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit.
For further information, contact STERIS Field Service Dispatch at 1-800-8828.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lamp, surgical - Product Code FTD
Causa
Premature bulb failure.
Acción
STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit.
For further information, contact STERIS Field Service Dispatch at 1-800-8828.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lamp, surgical - Product Code FTD
Causa
Premature bulb failure.
Acción
STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit.
For further information, contact STERIS Field Service Dispatch at 1-800-8828.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There is incorrect barcode information, which can potentially cause the alert message "calibrator insert missing" to be displayed.
Acción
The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Assay, glycosylated hemoglobin - Product Code LCP
Causa
The results from the blood device had the occurrence of some ramping baselines on their chromatograms. the ramping baseline can affect quantitation of the blood results.
Acción
The firm, Bio-Rad Laboratories, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department.
If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Upc Reader (bar code reader) - Product Code RFZ
Causa
There is a mismatch between the class of the laser barcode scanner and the labeling of the hemochron signature elite: some of the devices were inadvertently equipped with class ii laser barcode scanner instead of the intended class i barcode scanner.
Acción
Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
brain oxygen probe - Product Code GWM
Causa
One probe that had failed a product release test was inadvertently packaged and released into inventory in integra's distribution center.
Acción
An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Set, i.v. fluid transfer - Product Code LHI
Causa
Molding defect in the valve body causes leaking.
Acción
Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm.
For further information, contact Baxa Corporation at 1-303-617-2242.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Utrasound imaging device - Product Code IYN
Causa
Image captured from the device may be erroneous.
Acción
Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
halo system - Product Code HWC
Causa
Sterility of device is compromised due to loss of package integrity.
Acción
DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Tape - Product Code KGX
Causa
Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
Acción
An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M.
A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
Causa
Specific lots no longer meet their stated limit of detection claims of 2000 miu/ml for the ucg-slide test and 500 miu/ml for the ucg-beta slide monoclonal ii test.
Acción
The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
Causa
Specific lots no longer meet their stated limit of detection claims of 2000 miu/ml for the ucg-slide test and 500 miu/ml for the ucg-beta slide monoclonal ii test.
Acción
The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.