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
Wire, guide, catheter - Product Code DQX
Causa
Reports of no signal displayed on the monitor when flowire doppler guide wires were connected to the combomap.
Acción
Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory.
For questions regarding the use of the product. customers were instructed to contact their Sales Representative.
For questions regarding this recall call 916-281-2790.
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.
As part of stryker¿'s quality process, a packaging discrepancy was identified in specific lots of stryker¿'s duration¿ packaging.
Acción
Stryker sent an Urgent Product Recall notification letter and Product Recall Acknowledgment Form dated September 6, 2011 to all affected consignees via FedEx with return receipt. The letter identifed the product, problems, potential hazard, and instructions on how to handled the affected product. Consignees are instructed to Return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics. Consignees are advised to completed and fax back the attached Product Recall Acknowledgment Form within 5 days to (201) 831-6069. For questions call (201) 972-2100.
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
System, x-ray, tomography, computed - Product Code JAK
Causa
The common image reconstruction system (cirs) on the affected brilliance systems encounters an error and requires reboot of the system. the unit failed to initialize axial scan due to timeout that occurred waiting for "ready" state.
Acción
On 10/10/2011 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected products, the problem, the hazard involved, the action to be taken by the customer, and actions planned by Philips. Customers were to reboot their systems if the two possible scenarios occurred. Philips Healthcare plans on installing the update through a Field Change Order free of charge. For further information or support concerning the issue, contact a local Philips representative or local Philips Healthcare office. In North America and Canada, contact Customer Care Solutions Center at 1-800-722-9377, option 5.
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.
Syringes packaged and labeled as the illumena 150ml linden luer syringe with handi-fil straw, product 900103, contained the illumena 150ml syringe with handi-fil straw, product 900101.
Acción
The firm, Covidien, sent an "URGENT DEVICE RECALL" letter dated October 11, 2011 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their inventory, if any of the affected lots are found, discontinue use of the lots immediately; complete and return the BUSINESS RESPONSE FORM even if they do not have any of the affected lots via fax to (314) 654-8206 or email to imaging.recalls@covidien.com by October 28, 2011; return product and notify any consignees that this product may have been distributed to.
If you have any questions about this recall, contact our Product Monitoring department at 800-778-7898.
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
Antigens, all groups, streptococcus spp. - Product Code GTY
Causa
Alere san diego is expanding the scope of the voluntary recall of the strep a rapid test cassette and twist devices from the single lot that was recalled in january 12, 2011 to all lots of product that were on the market within the expiry period.
Acción
The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form.
Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.
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
Antigens, all groups, streptococcus spp. - Product Code GTY
Causa
Alere san diego is expanding the scope of the voluntary recall of the strep a rapid test cassette and twist devices from the single lot that was recalled in january 12, 2011 to all lots of product that were on the market within the expiry period.
Acción
The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form.
Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.
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.
Philips became aware of an issue relating to a ups cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
Acción
Philips Medical Systems (Cleveland) Inc communitcated the problem to the facilities via telephone. No customer letter was sent since the correction was already performed by the supplier.
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.
A system database corruption may occur that causes the v series monitor to reset.
Acción
The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility.
If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: d.arpino@mindray.com.
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.
Low buffer fill volumes on oral-eze, an oral fluid collection system.
Acción
Thermo-Fisher Scientific/Capital Vial sent a Recall Notification letter dated October 7, 2011 to the sole consignee. The letter identified the affected product, problem, result impact and necessary actions to be taken. The consignee was instructed to discontinue use of the affected product and follow the necessary actions provided. If you have any questions regarding this information, call Michael Hect, Manufacturing Manager through Customer Service at (800) 772-8871.
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
Chair, with casters - Product Code INM
Causa
On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
Acción
Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.
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
Chair, with casters - Product Code INM
Causa
On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
Acción
Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.
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.
A small number of non-conforming cusa excel 23 khz standard tip and flue (item number c4601s) were released for distribution that did not meet integra's in-process requirements for release. it was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts, causing the stroke range of the tip to exceed it required range by up a value up to 0.002 inches.
Acción
Integra sent an Urgent Product Recall Notification letter dated October 14, 2011 to all affected customers via US Mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, discontinue use, quarantine and return any available affected lot numbers. Customers were instructed to distribute this communication to any customers to whom they have shipped the affected product. Customers were advise to complete the enclosed Recall Acknowledgement and Return Form and return it as soon as possible to Integra Customer Service. For questions contact Integra Customer Service at 609-936-2659.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The recall was initiated because beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the access total bhcg assay.
Acción
Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their 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.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The recall was initiated because beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the access total bhcg assay.
Acción
Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their 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.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The recall was initiated because beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the access total bhcg assay.
Acción
Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their 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.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The recall was initiated because beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the access total bhcg assay.
Acción
Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their 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.
Notas adicionales en la data
Dispenser, liquid medication - Product Code KYX
Causa
There are complaint reports for loose tip caps in various types of oral syringes.
Acción
Becton Dickinson (BD) sent an Urgent: Product Recall letters dated October 5, 2011 to all affected consignees. The letter identifies the affected product, problem and actions to be taken. Customers are instructed to follow the instructions on how to handle the affected product: 1) Check their inventory to determine if they have any Oral Syringe Tip Caps from the impacted lot numbers. 2) If they have any of the impacted product return the Oral Syringe Tip Caps to BD for replacements as directed on the attached recall packing list. 3) If they use the Oral Syringe Tip Caps and require replacement, follow the instructions on the attached form. 4) If they have no inventory of the affected lots, indicate this on the website.
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.
An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
Acción
Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.
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 cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
Acción
BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit.
For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions.
For questions regarding this recall call 918-563-1624.