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
orthopedic instrument - Product Code LXH
Causa
The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.
Acción
Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.
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
Diagnostic Biliary Catheter - Product Code FGE
Causa
Boston scientific corporation is initiating an urgent field correction related to its flexima¿ and percuflex¿ drainage catheter family (pigtail style). during the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
Acción
Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement 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
Ureteral Stent - Product Code FAD
Causa
Boston scientific corporation is initiating an urgent field correction related to its flexima¿ and percuflex¿ drainage catheter family (pigtail style). during the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
Acción
Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement 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.
Malfunction of the j3 connection between the heater plate main printed circuit assembly (pca) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier pca.
Acción
A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices. The communication described the affected device and actions required.
Further questions may be addressed by phone at 1-800-345-6443, and by email at service@respironics.com or clinical@respironics.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
Motor, Surgical Instrument, Pneumatic Powered - Product Code GET
Causa
Potential compromise of sterile packaging for disposable dissecting tools.
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
microspheres radionuclide - Product Code NAW
Causa
Instructions for the use of the pinch clamp that is an integral part of the therasphere administration set were not included with the distribution of the device.
Acción
A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions.
For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.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
Repetitive transcranial magnetic stimulator for treatment of major depressive disorder - Product Code OBP
Causa
Senstar treatment link may have an open circuit that during use with the neurostar tms therapy system may cause arcing and heat damage to the senstar and/or treatment coil. heating of the senstar during use has a potential risk of minor scalp burn to patients.
Acción
Neuronetics Inc. notified consignees by telephone and sent a follow-up fax/letter dated March 19, 2009 titled "Urgent Product Recall Notification." The letter describes the issue and actions for consumers to take in response to the recall. Neuronetics will visit each customer in person to complete a "Returned Goods: SenStar Recall Inventory Form."
Customer questions should be directed to Neuronetics Customer Service at 1-877-600-7555.
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
Light Based Over The Counter Wrinkle Reduction - Product Code OHS
Causa
Sybaritic stated that no 510(k) has been filed for the device (lumi 8 intense led light facial system).
no injuries or illness reported.
Acción
Letter sent to consignee on June 18, 2008 confirming a phone conversation on June 18 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA. The customer was asked to allow the technician access to their LUMI 8 system; allow technician to replace the computer chips and owner's manual; give current LUMI 8 owner's manual to technician; and sign the work order provided by the technician. Questions should be directed to Fred Berg at 800-445-8418 or fberg@sybaritic.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.
Lead connection issues or fracture increases probability of inappropriate therapy: inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.
Acción
Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.
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.
Lead connection issues or fracture increases probability of inappropriate therapy: inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.
Acción
Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.
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
body chamber - Product Code ISA
Causa
Misbranded and sale without pre-market notification.
Acción
Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.
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
Protective Cover, Barrier - Product Code MMP
Causa
Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have sterile seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state.
Acción
Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.
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
Intramedullary Fixation Rod and Accessories - Product Code HSB
Causa
Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
Acción
Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
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
Intramedullary Fixation Rod and Accessories - Product Code HSB
Causa
Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
Acción
Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
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
Cylinder, compressed gas, and valve - Product Code ECX
Causa
Firm received reports from customers that valves malfunctioned when installation and/or filling process. customers forwarded pictures of the defect where the top portion of the packing nut broke off from the threaded portion of the net; which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Acción
Intermed Gas Products Corporation notified customers of the affected product by phone beginning March 27, 2009 and followed up with a formal "Product Recall Notice" letter dated March 31, 2009. All affected product should be located and returned to the firm for replacement.
For further information, contact Intermed Gas Products at 1-561-483-1364.
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
Retractor - Product Code GAD
Causa
The recall was initiated after alphatec spine received a complaint on the illico posterior thoracolumbar access retractor. it was reported that one of the retractor arms in the retractor broke during surgery.
Acción
On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.
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 "Urgent: Medical Device Recall" letter dated February 6, 2009 was sent to all affected Synthes Trauma Sales Consultants via USPS certified mail on February 09, 2009 and affected In House employees were notified via return receipt email on February 09, 2009. All affected hospitals were notified of the recall through a notification letter mailed via USPS certified mail on February 09, 2009. The notification letter described the affected product, issue and actions for recipients. Direct questions about the recall to Synthes Spine by calling 800-620-7025, Extension 5455 or 610-719-5455.
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 instructions - Product Code ODP
Causa
Tip breakage, due to inadequate instructions for use. the technique guide provided incorrect information related to use of the torque limiting attachment during screw insertion and final tightening.
Acción
All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.
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.
Medtronic has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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.
Medtronic has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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.
Medtronic has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
Acción
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product.
For further questions, contact Medtronic at 1-763-514-9605.
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
stress treadmill - Product Code IOL
Causa
28 stress and rehab treadmills manufactured between september 2006 and january 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. if these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. because safety testing may not have allowed for complete evaluation of the el.
Acción
On April 3, 2009 the recalling firms notified consignees by certified letter to domestic customers and via FedEx to international customers with delivery confirmation signature required. Customers were advised to remove treadmill from service until it is tested by a Field Service Engineer.
For customers with questions or those that have not already scheduled a service call with Cardiac Science Field Service Engineers, please contact the firm at 1.800.426.0337, option 1.
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
Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Causa
The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.
Acción
GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.
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, percutaneous - Product Code DQY
Causa
Boston scientific has initiated a recall of the wiseguide guide catheter. they have received reports of difficulties in connecting the product hubs with the y-adaptors and toughy borst connectors. if there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. there have been 41 complaints in the us as.
Acción
Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form.
Further questions can be addressed to Boston Scientific at 763-494-1634.
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.
Milcam recon iii models were sold to non-dod customers prior to certification and reporting as required in title 21 of the code of federal regulations. conditions of sale were not stated in variance approval letters issued for similar laser products.
Acción
FLIR Systems notified direct account by letter of the Corrective Action Plan and updated certification label that references CDRH issued variance and instructions on how to install it.