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
probe, radiofrequency lesion - Product Code GXI
Causa
Name of the device reflected on the product packing sleeve is incorrect.
Acción
The firm, Baylis Medical, notified US Distributor by email and sent a "URGENT Field Corrective Action Notice" dated May 12, 2010, to customer. The notifications described the product, problem and action to be taken by customer. The customers were given the follow options: Option 1: In order to prevent confusion in identification of the product before use, please immediately remove and dispose the package sleeve that covers the tray packaging of the LumbarCool Pain Management Kit.
Option 2: Alternatively, you may exchange your kit from Lot LKFA160310 with a correctly labeled replacement LumbarCool Pain Management Kit by contacting Kimberly-Clark Health Care sales representative. The customers were ask to fill out the Field Corrective Action Acknowledgment and return it.
Any question please call Baylis Sales Representative at 905-602-4875 and/or contact your local sales representative for any further information you may require.
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.
Ev3 has initiated a voluntary removal of two lots of axium detachable coil system for product mislabeling as the lots were swapped in production.
Acción
Micro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline.
a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots.
b) Based on the Health Hazard Assessment, the risk was considered undesirable.
c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed.
d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated.
e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition.
f) The ev3 Neurovascular Quality Assurance department scrapped the affected product.
g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.
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.
Ev3 has initiated a voluntary removal of two lots of axium detachable coil system for product mislabeling as the lots were swapped in production.
Acción
Micro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline.
a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots.
b) Based on the Health Hazard Assessment, the risk was considered undesirable.
c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed.
d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated.
e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition.
f) The ev3 Neurovascular Quality Assurance department scrapped the affected product.
g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.
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
Culture media, selective and differential - Product Code JSI
Causa
Diagnostic test reagents may not meet quality control specifications.
Acción
The recalling firm notified distributors by letter flagged as "Urgent Product Recall" on 12/09/09. The letter instructed distributors to discontinue distribution and discard product. Distributors were asked to provide customer lists and the recaller subsequently notified the end users to discontinue and discard identified lots for replacement. Customers were asked to return a response form.
If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
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
Bone grafting material, synthetic - Product Code LYC
Causa
Fast set 4% potassium sulfate solution may not be sterile. for customers who have used the calcium sulfate hemihydrate kit without the fast set solution, then these potential risks identified do not apply. risks of adverse health consequences with the fast set 4% potassium sulfate solution include tissue inflammation and infection.
Acción
Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits.
Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.
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
Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
Causa
Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
Acción
Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to:
1) Identify affected product in inventory
2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21
3) Complete and return an enclosed Customer Reply Form
4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22
5) For AEROSET Systems, manually update parameters as described in the letter.
6) For ARCHITECT cSystems, implement alternative kit sizes without system changes.
7) Provide a copy of the letter to other laboratories that have been distributed the affected product.
US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
Acción
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
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 sterility of the product may be compromised. integra lifesciences corp. received a recall notification from saint-gobain performance plastics, france, contract manufacturer of the integra suction reservoir with anti-reflux valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.
Acción
Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form"
Integra LIfeSciences can be contacted at 609-936-2495.
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
Counter, Differential Cell - Product Code GKZ
Causa
The recall was initiated after beckman coulter identified four (4) issues with the coulter lh 500 series system and the unicel dxh 800 coulter cellular analysis system:
issue 1:
there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. the issu.
Acción
The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around.
Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United
States or Canada, or contact your local Beckman Coulter Representative.
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.
Mistreatment-- the database conversion utility used during the upgrade errantly changes the start gantry angle to zero. any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
Acción
ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers.
Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery.
Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately.
A workaround was to be re-imported into their current version of MOSAIQ.
IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans.
For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.
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.
Samples prepared on the bd spa ii, sn t0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe.
Acción
The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.
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
Catheter, continuous flush - Product Code KRA
Causa
This lot was packaged with the wrong occluding ball guidewire. the pulsespray catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.
Acción
Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax.
For further information, contact Angiodynamics Customer Service at 1-800-772-6446.
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.
Stryker spine has received reports of breakage of the distal end of the avs tl spacer trial during the trialling step of the avs tl procedure.
Acción
Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.
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.
Stryker spine has received reports of breakage of the distal end of the avs tl spacer trial during the trialling step of the avs tl procedure.
Acción
Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.
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.
Stryker spine has received reports of breakage of the distal end of the avs tl spacer trial during the trialling step of the avs tl procedure.
Acción
Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.