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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Manufacturing residue may be present on the cervical
screws. use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Acción
Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
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
Pump, infusion, elastomeric - Product Code MEB
Causa
Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
Acción
Symbios sent an Urgent Medical Device Recall letter dated February 25, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to follow the enclosed 'Steps for Voluntary Field Action' in their entirety. These steps contain information about: I) identifying the product to be returned, 2) obtaining a Returned Goods Authorization number, and 3) returning the recalled product. If product(s) is (are) located, please call 317-450-0145 from 7:00 a.In '0 5:00 p.m. EDT to receive a Returned Goods Authorization umber ("RGA"). Please indicate the RGA number on the outside of the package. Attached is a Verification Form. Customers were instructed to complete and return the form even if they do not have any product to return. Their local sales representative can assist them in completing this form. Distributors of the affected product were instructed to contact Symbios at the number provided and forward the recall notice to all their affected accounts.
For questions regarding this recall call 317-225-4447.
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 bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
Acción
Zimmer sent an Urgent Device Removal letter dated February 14, 2013, to all affected consignees. The letter identified the product, the problem,and the action to be taken by the consignee. Consignees were advised to review the notification letter, follow the instructions contained in the letter, remove from use and quarantine the affected product. Consignees were also instructed to complete and return the fax back from to 877-787-0375 or zimmer3632@stericycle.com. Consignees were instructed to return the affected product back using the shipping label provided. If affected product was further distribution, consignees were asked to provide the customer's information to the firm on the back of the form. For questions regarding this recall call 866-201-9081.
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
Introducer, catheter - Product Code DYB
Causa
Bard access systems is recalling two lots of hickman 9.0 french and one lot of leonard 10.0 french dual lumen catheters with surecuff tissue ingrowth cuff with peel-apart percutaneous introducer systems due to the wrong size introducer being included with the kit.
Acción
Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.
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
Introducer, catheter - Product Code DYB
Causa
Bard access systems is recalling two lots of hickman 9.0 french and one lot of leonard 10.0 french dual lumen catheters with surecuff tissue ingrowth cuff with peel-apart percutaneous introducer systems due to the wrong size introducer being included with the kit.
Acción
Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689.
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.
Lifepak cr plus or lifepak express automated external defibrillators (aeds) are recalled due to the potential to experience an early internal battery depletion issue.
Acción
The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees.
Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present.
In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device.
Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.
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
Scalpel, one-piece - Product Code GDX
Causa
Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
Acción
MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535.
For questions regarding this recall call 919-460-2535, ext 105.
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
This field change order is being released to update software and customer release notes to the affected installed base.
Acción
Philips Healthcare sent an Urgent Medical Device Correction letter dated February 13, 2013, via certified mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter. Customers were instructed to retain a copy with the equipment Instruction for Use. For questions customers were instructed to contact their local Phillips representative or local Philips Healthcare office. For North Americal and Canada contact Customer Care Solutions Center at 1-800-722-9377, option 5: Enter Site ID or follow the prompts
For questions regarding this recall call 1-800-722-9377.
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.
Intio inc. distributed a svm user's manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Acción
INTIO sent a Recall Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. INTIO has corrected this version of the SVM User's Manual. An INTIO Inc. employee will contact the customers to replace the current manual with the correct one. Consignees were notified by letter that an INTIO Inc. employee will contact you within the next 30 days to replace the current manual with the correct one. The new SVM User's Manual will be provided to you once INTIO Inc. has retrieved the incorrect version of the SVM User's Manual. Customers with questions were instructed to email support@intio.us or call 303-396-1777.
For questions regarding this recall call 303-396-9291.
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 anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
Acción
The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887.
For questions regarding this recall call 561-494-3706.
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
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Causa
There is a potential for lead damage due to the use of the lead cap provided in dbs and dystonia kits. medtronic has received reports of dbs leads being damaged at the connector end of the lead when the lead cap is used. the connector end of the lead is the end of the lead connected to the lead extension. tightening or loosening of the setscrew may twist the setscrew connector block and may damag.
Acción
Medtronic sent an Urgent Medical Device Correction letter dated February 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to follow the modified instructions if the lead cap is used during the implant procedure. For questions call Medtronic Neuromodulation Technical Services 1-800-707-0933.
UPDATE: Medtronic mailed an Urgent: Medical Device Removal notification to customers on June 07, 2013, who may have unused DBS lead kits that were manufactured prior to the process change to correct the issue. On June 10, 2013 Medtronic representatives began visiting the identified accounts to facilitate removal of any unused product. The Medtronic Rep documented the hospital visits on an Account Specific Customer Confirmation Form and left a copy with the Hospital.
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, for isolation of pathogenic neisseria - Product Code JTY
Causa
Increased levels of false positives in bd probe tech neisseria gonorrhoeae q amplified dna assay kits.
Acción
BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter via UPS overnight delivery on February 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to verify that these kits have been consumed, returned or destroyed by completing the enclosed form. The firm will issue a no charge replacement for customers' product. Any product remaining in customers' inventory should be discarded or destroyed per their facility procedures. Complete the attached form regardless if any inventory remains, so that the firm may acknowledge customers' receipt of this notification. It is not necessary to contact BD by telephone to receive replacements. Complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 OR E-mail to RegulatoryComplianceFax@BD.com. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908.
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 displayed value for the invasive blood pressure measurement of the iacs was different than the actual patient values. liquid ingress in the cable connection may cause inaccurate measurements. this can happen if the dual hemo mcable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Acción
Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.
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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
The affected product was packaged with the incorrect introducer needle. the kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Acción
Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201
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
Pump, infusion, insulin bolus - Product Code OPP
Causa
Update instruction for use for preventative maintenance (pm) schedule and addition of odometer software to monitor accumulative fluid volume infused by the pump.
Acción
Zyno Medical initiated recall 6/13/11 to accounts advising of a Preventative Maintenance (PM) Schedule and a software upgrade Odometer to monitor counts of accumulative fluid volume infused by the unit. On 3/1/13, firm issued correction notice to users that have not had the software implemented on their unit. Units will be serviced at their scheduled PM. The notice identified the product, problem, and actions to be taken by the customers.
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
Screwdriver - Product Code HXX
Causa
Increased risk of failure at the driver tip during screw insertion or removal.
Acción
Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC.
Please follow the instructions on the enclosed "FAX Back Response Form, "
and fax a copy of the Response Form to (973) 257-0232, prior to return of the items.
Questions related to this notice should be directed to (973) 299-9300 ex. 2322.
Monday through Friday, 8am to 5pm.
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
real time Nucleic acid amplification system - Product Code OOI
Causa
Certain lots of reagent reservoirs, may not have a separation in the lower part of the reservoir. as a consequence, pipetting errors can occur due to uneven distribution of reagent. these pipetting errors may lead to delayed results and wasted reagent.
Acción
Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers.
Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made.
Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.
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.
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Acción
The firm initiated their recall of these products beginning on January 4, 2013 by sending notification letters to their consignees via electronic mail and/or facsimile. Customers were asked to return the affected product for a replacement.
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 standard triathlon femoral stylus does not fit into the specialty sizers and the "r" and "l" markings on the right sizer are reversed.
Acción
A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.
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
PICC - Product Code LJS
Causa
Product was packaged with the incorrect introducer needle. the kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Acción
Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
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.
Vital images has found a potential error in measurement generated through the software which affects all versions of vitrea enterprise suite, vitrea, vitreaadvanced, vitreacore (vitalconnect) and vitrea fx prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3.
this error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia.
Acción
Vital Images sent an "Urgent Field Safety Notice' letter dated February 5, 2013, to all affected customers. The letter identified the probelm the product and the action needed to be taken by the customer.
Please immediately inform all potential users of Vitrea of the information contained in this letter. We recommend that all measurements associated with the error described in this letter be verified against results from other technologies.
You will be contacted by Vital Images Customer Support or by the customer support department of your distributor to arrange for installation of this patch on your system. We recommend that you implement the patch. If you have an earlier version, Vital Images Customer Support or your distributor will contact you to discuss your options for replacement.
Please sign this Notice in the space below to verify that you have received and understood it, and return your signed Notice by email to fieldnotices@vitalimages.com.
If you have questions, direct customers of Vital Images should contact Vital Images Customer Support at 1-800-208-3005 or by e-mail to support@vitalimages.com; customers through a distributor of Vital Images products should contact that distributor.
Updated 5/28/2013:
A second consignee Vital Images, Inc "Urgent Field safety Notice" letter dated March 26, 2013 was sent to consignees on 3/25/13. The follow-up letter was sent via e-mail and mail to 4,616 already-notified consginees, who had received affected versions 6.3.0, 6.2.3, or 6.1.6. The letter described the problem and the affected product being recalled and provided a number of steps to follow which included to retun the Effectiveness Check form.
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
Siemens healthcare diagnostics has initiated a voluntary field action for dimension(r) phos flex(r) reagent due to reagent interaction causing falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent.
Acción
Siemens sent an Urgent Medical Device Correction letter dated February 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Action to be taken by Customer:
1. Customers with two or more Dimension systems should perform testing of PHOS and EZCR on separate Dimension systems.
2. Customers with only one Dimension system should discontinue use of either PHOS or EZCR on the Dimension system. Please contact your local sales representative to discuss alternate solutions that will best meet the needs of your laboratory.
Please complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at (302) 631-8467, to indicate you have received the information. If you have any questions, please contact the Siemens Technical Solutions enter or your local Siemens technical support representative.
We apologize for the disruption this situation will cause your laboratory. We are working diligently to resolve this issue with a permanent solution.
.
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 label on the device states that the item number is clgy-2210 when the item number on the device label should read clgy-2010. this is a 20ga huber needle set; however, the product label states the pouch contains a 22ga set.
Acción
Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
For questions regarding this recall call 603-743-5988.
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 dimensional mismatch was identified which can potentially allow for interference between devices.
Acción
Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Customers were instructed to immediately cease distribution or use of these products.
2. Extend this information to your accounts that may have this product in their possession.
3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots.
Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter.
For further questions please call (352) 377-1140.
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
Quality control slides - Product Code LJG
Causa
Microbiologics inc is initiating a voluntary recall on products kwik-qc acid fast stain slide, sl42-10 and kwik-qc mycobacterium, sl43-10. these products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. this contamination could pote.
Acción
Microbiologists an "Urgent Medical Device Recall" letter dated February 11, 2013. The Letter described the product and the reason for the recall. Advised consignees to "Do not Distribute" and "Return" the product. Urged consignees to "Notify" end users and to complete the attached "Recall Response Form". Contact the form at 320-229-7057 for questions regarding this notice.