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 Surgical Instrument Ac-Powered Motor and Accessories/Attachments - Product Code HWE
Causa
These surgical instruments are etched with incorrect measurement markings.
Acción
Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.
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
Toe Polymer Constrained Prosthesis - Product Code KWH
Causa
Tornier, inc. has received a report of a mislabeled product due to a product mix-up. the package label indicated that the product was a model lmp-50 however the product inside the package was tornier fgt-50 implant (primus flexible great toe implant with grommetts).
Acción
Consignees were sent on April 6, 2009 a Tornier "Urgent-Product Recall" letter dated April 3, 2009. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.
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.
Co2 detector may increase resistance to air flow in an intubated patient.
Acción
Covidien issued an Urgent Medical Device Recall letter dated August 14, 2009 informing Consignees of the affected devices. Users were told to stop use and arrange for return of all affected product.
For further information, contact Covidien at 1-800-635-5267.
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
Contact Lens Solution - Product Code LPN
Causa
During routine testing the product failed to meet shelf life specifications.
Acción
Consignees were notified by letter on/about August 17, 2009. All consignees were asked to review their inventory and return any of the affected product to Stericycle Pharmaceutical Services.
For questions about the recall process or need additional shipping labels, please contact Stericycle Inc. at 1-888-345-83 16. For questions regarding this recall, please contact Bausch & Lomb's Customer Resource Center at 1-800-828-6974.
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.
Failure to conduct important safety checks when using the brainlab radiotherapy treatment planning software in combination with brainlab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.
Acción
BrainLAB AG issued an "Urgent Field Safety Notice" letter dated August 12, 2009 informing all customers of the BrainLab radiotherapy planning software using conical collimators of the important safety checks to avoid the failure to apply and verify an adequate jaw-shaped field size and field position at the LINAC for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator. Consignees were instructed on proper steps to take to avoid further issues. For further questions, contact BrainLAB AG by phone at 1-800-597-5911.
*** On February 1, 2010, BrainLab sent supplemental letters to 50 of the accounts who received the August 12, 2009 letter and have Novalis Dose Delivery Systems (excluding all Novalis Tx systems). The accounts were informed that in addition to the safety checks listed in the August letter, BrainLab will be installing a mandatory software modification on their systems that limits the field size to a maximum of 4x4 cm2 when the conical collimators are inserted. The accounts would be contacted by a service representative within the next six weeks to schedule the update. Any questions were directed to BrainLab at 1-800-597-5911. ***
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.
Vistakon is recalling acuvue advance for astigmatism diagnostic product for mislabeling.
Acción
Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.
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
Coronary drug-eluting stent - Product Code NIQ
Causa
The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and instructions for use.
Acción
The firm, Medtronic, sent their initial "Urgent Medical Device Recall Notice" to customers with affected product via e-mail on August 7, 2009. An additional "Urgent Medical Device Recall Notice" was sent to all customers on August 12-13, 2009 via FedEX and UPS. The notice described the product, problem and action to be taken by the customers. The customers were instructed to remove the affected units from their inventory and isolate the units in a secure location to prevent additional use. A Medtronic CardioVascular Clinical Customer Service (CCS) representative will contact their site to arrange for return of the units. This will be followed by a shipment of replacement units to their sites. If there were any questions regarding the return process, customers were to contact CCS at 800-556-4247.
If you have any further questions or concerns regarding this notice, please contact the Sr. Clinical Research Manager at 707-543-2284 or ann.depaoli@medtronic.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
Immunomagnetic circulating cancer cell selection and enumeration system - Product Code NQI
Causa
Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of cellsearch circulating tumor cell kit. delayed detection of disease relapse or progression may occur due to false low ctc results.
Acción
Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose 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.
The anspach effort, inc. is recalling the foot control/ foot pedal for sc2000 and sc2100 powered, simple cranial drills, burrs, trephines, and accessories. the foot control cables lacks the shield connection from the cable to the connector body. the lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal.
Acción
Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm.
For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.
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
medical gas cylinder connectors - Product Code CAN
Causa
Yoke may become displaced. yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Acción
Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.
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
medical gas cylinder connectors - Product Code CAN
Causa
Yoke may become displaced. yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
Acción
Airgas issued a Medical Device Removal letter dated 8/6/09 to its customers informing them of the problem and the need to have a yoke back-up plate installed on the Manifold Block Assembly.
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 l atitude¿ communicator (model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. the issue has been resolved. if any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to latitude after the patient's communicator calls in to boston scientific's servers. it.
Acción
Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009.
Direct questions about the recall to the LATITUDE Customer Service by calling
1-651-582-4000.
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.
Some lifepak 15 monitor/defibrillators have a non-invasive blood pressure (nibp) module that was supplied by cas medical systems, branford, connecticut who is recalling the modules. the nibp modules may be susceptible to sudden changes in cuff pressure. sudden changes in cuff pressure may possibly be caused by bumping or squeezing the
cuff. in some instances this may result in a screen display.
Acción
The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time).
.
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
St. jude medical has initiated a voluntary recall of two lots of fast-cath hemostasis introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. they discovered that the product lots could contain some items which have been mis-labeled with the incorrect french size. in one case, the pouch label does not correctly identify the content of the pouch. in another.
Acción
Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm.
Contact your local St Jude Medical representative for further information.
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
St. jude medical has initiated a voluntary recall of two lots of fast-cath hemostasis introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. they discovered that the product lots could contain some items which have been mis-labeled with the incorrect french size. in one case, the pouch label does not correctly identify the content of the pouch. in another.
Acción
Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm.
Contact your local St Jude Medical representative for further information.
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.
I-flow identified a b. braun syringe package that had a tear/hole in the paper portion of the primary package.
Acción
I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately.
They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt.
The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
I-flow identified a b. braun syringe package that had a tear/hole in the paper portion of the primary package.
used to provide an optional filling device for the easypump.
Acción
I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately.
They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt.
The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Template - Product Code HWT
Causa
The trial stems were manufactured using the wrong design.
Acción
The firm notified their consignees of their product recall by parcel post on 07/16/2013.
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.
Some units of the total knee junior produced between november 25th, 2008 and through april, 2009 contain balancing units that may fail under extreme use over a long period. the fault is noncritical and no incidents or injuries resulting from this situation have been reported to ossur at this stage. over long term use (estimated to be in the four to six year range) the prosthetic device may fail a.
Acción
Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.
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
Picture archiving and communications system - Product Code LLZ
Causa
Under certain circumstances, software version 2.1.0 has potential for incorrect data imaging and patient identification.
Acción
Firm sent notifications to all ILUMAVision customers on 8/3/2009 and offered upgraded software. The notification letter indicated the the reason for the recall and identified the potential issues associated with the device. Contact 3M IMTEC Technical Support at 1.800.879.9799, if there are any questions.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Digital Image Storage Radiological Device - Product Code LMB
Causa
Guardian services data backup does not contain 100% data for all orthopad customers on a daily basis.
Acción
Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.
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
Cover, barrier, protective - Product Code MMP
Causa
Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state. eleven complaints and 3 mdr's have been filed. no illness or injuries reported.
Acción
GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response 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
Cover, barrier, protective - Product Code MMP
Causa
Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state. eleven complaints and 3 mdr's have been filed. no illness or injuries reported.
Acción
GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response 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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Fire/shock hazard-- the power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
Acción
Hospira initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and a letter to consignees was sent via UPS. The firm will replace affected cords and effectiveness checks will be conducted through tracking of servicing.
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
Cover, barrier, protective - Product Code MMP
Causa
Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state. eleven complaints and 3 mdr's have been filed. no illness or injuries reported.
Acción
GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.