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.
Customer contacted biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). biomedix performed extensive investigation and found insufficient application of glue. recall was initiated due to the rate of the failure.
Acción
Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge.
Please call (1-800-627-2765 ) for further 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.
Integra lifesciences corporation received 2 complaints that the usb port on the licox pt02 monitor does not consistently provide the user the ability to extract the pt02 trend data according to the user's manual for the device.
Acción
Integra LifeSciences sent an "Urgent Voluntary Medical Device Correction" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer.
Complete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below.
If you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers
for the affected monitors you have and record the total quantity.
Complete the other information on the form and return the form by email or fax as indicated. Keep a copy of the form for your records.
When your form is received, Integra will schedule this service with your facility and provide a temporary loaner monitor to minimize any disruption this action may cause.
Should you have any questions, please contact Neuro Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
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 - Product Code LZG
Causa
The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. if the capacitor fails, the time and date will return to default setting. though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Acción
Roche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
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
Assay, glycosylated hemoglobin - Product Code LCP
Causa
In march, siemens healthcare diagnostics issued an urgent medical device correction for decreased recovery of patient samples with the dimension vista® csa & csae flex® reagent cartridges when whole blood samples are run from small sample containers (ssc). siemens has confirmed that when whole blood samples are run from ssc, hba1c values may exhibit a percent bias ranging from - 8.2% t.
Acción
An Urgent Medical Device Correction, dated August 2014, was provided to all Dimension Vista¿ HbA1c customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by 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.
Ameditech is recalling the arcpoint labs dip drug screen dip card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
Acción
A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at amd.complaint@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.
Ameditech is recalling the arcpoint labs dip drug screen dip card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
Acción
A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at amd.complaint@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.
Sterilmed, a division of johnson & johnson medical nv/sa (sterilmed), has become aware of an issue affecting certain lots of reprocessed soundstar® eco diagnostic ultrasound catheters for which sterilmed is the reprocessor and biosense webster is the distributor. sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne.
Acción
Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions requested on your part:
1. Read the Description of the Problem section below carefully.
2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used.
3. Maintain a copy of this letter with the affected product.
4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form.
5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form.
6. Pass on this notice to anyone in your facility that needs to be informed.
7. If any of the affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return.
8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster.
For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.
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, stationary - Product Code KPR
Causa
Loss of key image functionality due to a bent pedal of the footswitch.
Acción
Field Safety Noticed was mailed on September 24, 2014 via Certified Return Receipt. This FCC consists of a Mechanical Hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoro images or exposures.
Customers with questions were instructed to contact their local Philips 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
Template - Product Code HWT
Causa
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Acción
Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letters dated September 24, 2014, via FedEx overnight to affected customers. The notification included a description of the reason for recall, instructions for responding to the formal recall notification, and affected product, actions to be taken. For questions call (574) 372-1570.
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, angiographic - Product Code IZI
Causa
Loss of key image functionality due to a bent pedal of the footswitch.
Acción
Field Safety Noticed was mailed on September 24, 2014 via Certified Return Receipt. This FCC consists of a Mechanical Hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoro images or exposures.
Customers with questions were instructed to contact their local Philips 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
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
Causa
Product lot did not meet the specification for its disinfectants at the time of manufacture.
Acción
Consignees were notified via letter starting 09/25/2014.
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
Passer - Product Code HWQ
Causa
An investigation identified that high level friction may exist between the needle and mamba suture passer instrument, causing the needle to break during use.
Acción
On 9/26/2014, "URGENT MEDICAL DEVICE RECALL NOTICE" notifications were sent via courier to the affected distributors with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, contact information, and instructions for responding to the formal recall notification.
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
Station, pipetting and diluting, for clinical use - Product Code JQW
Causa
Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. this might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.
Acción
Tecan sent an Urgent Field Corrective Action letter dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Tecan has instructed field engineers to replace the ZAAP Motion Board in the Freedom EVO instrument. Your instrument was identified as affected and a Tecan Service Representative will contact you to arrange replacement of the board.
Please make sure that your internal controls would detect any possible dispense errors that might affect your application when using the instrument before replacement of the board. Alternatively, stop using the instrument until the board is replaced.
We apologize for any inconvenience this issue may have caused,and are implementing corrective and preventive actions to prevent recurrence. If you have any further questions, please contact your local Tecan Helpdesk for assistance.
For further questions please call (919) 361-5200 ext. 19519
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.
Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the ptn assay range.
Acción
Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed as follows:
" Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form.
" Siemens will replace any unused inventory of the affected lot at no charge.
We apologize for the inconvenience this situation may have cause. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support 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
Varnish, cavity - Product Code LBH
Causa
During an fda inspection, it was found that the products are being marketed without a cleared 510k.
Acción
On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669.
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
Varnish, cavity - Product Code LBH
Causa
During an fda inspection it was found that the products are marketed without a cleared 510k.
Acción
On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669.
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.
Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.
For questions regarding this recall call 727-443-0530.
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.
Devon light gloves contain splits or holes compromising the sterility.
Acción
Medtronic/Covidien initiated recall on April 16, 2015 via FedEx and certified mail
Customers were instructed to discontinue use of the product and return all inventory and kits to Medtronic (Covidien) -Attention: Devon" Light Glove 110 Kendall Park Lane. Atlanta, GA 30336.
If you have any questions contact your Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am to 6:30pm ET,
at (800) 882-5878.
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.
Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.
For questions regarding this recall call 727-443-0530.
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.
Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.
For questions regarding this recall call 727-443-0530.
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.
Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com.
For questions regarding this recall call 727-443-0530.
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
Clamp, vascular - Product Code DXC
Causa
Sam junctional tourniquet (sjt) auxiliary strap, model sjt 102 and sjt 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.
Acción
SAM Medical Products issued the press release on August 29, 2014 and the link is http://www.ireachcontent.com/news-releases/sam-medical-products-implements-voluntary-recall-of-its-accessory-axilla-strap-for-the-sam-junctional-tourniquet-273239381.html.
SAM Medical Products sent the "URGENT: MEDICAL DEVICE RECALL" letter, dated September 10, 2014, to their consignees.
The 5 additional lot numbers (7/1/14, 7/2/14, 8/4/14, 8/7/14, and 8/11/14) that were erroneously placed on the recall notification letter and they are NOT part of the recall.
SAM Medical Distributors will need to notify their customers via this letter and the included FAX Back document of the actions being taken as well as ship the replacement straps to individual customers.
Distributors will document and report to SAM Medical that all customers have been notified and replacement straps delivered to these customers. Distributors will notify SAM Medical that the replaced straps have been destroyed. This information will be documented on the included FAX Back document and then returned to SAM Medical (via FAX, e-mail, or mail, per
instructions on the FAX Back document).
Customers will receive one complete Auxiliary Accessory Strap at no charge with a reinforced metal clip as a replacement. Once received, the existing strap should be removed from the SJT and replaced with the new strap. Customers/End Users need to complete and return the FAX Back document to the distributor from whom the FAX Back was sent.
Customer can contact SAM Medical Customer Service at:
-Email customerservice@sammedical.com
-Phone (503) 639-5474, Monday through Friday, 7:30-4:30, Pacific Time
-Toll free l-800-818-4726
-Website: vww.sammedical.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.
The easy-care care-lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the care-lock system has been engaged by stepping on the red (locked) pedal.
Acción
Joerns sent an Urgent: Medical Device Correction letter dated September 24, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm will provide the customers with a temporary solution kit to safegard the bed until a replacement Care-Lock assembly can be shipped and installed. Customers were instructed to complete the response form. For questions call 800-826-0270.
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.
Product is not cleared for use with lasers other than the auriga xl system.
Acción
Boston Scientific sent an " Urgent Medical Device Recall Removal Immediate Action Required" letter dated September 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the account to check their inventory, remove any affected product from their inventory, and contact Boston Scientific for further instructions on returns.
The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory.
We ask that you complete and return the Reply Verification Tracking form, included with this letter, according to the instructions on page 3, even if you no longer have inventory of the recalled lots. If you identify any of the affected lots within your inventory, please segregate it immediately and you will be contacted by Boston Scientific with additional instructions after you return your form. You will receive credit, as appropriate, for any affected product in your inventory. Fax to : Field Action Center at 1-866-213-1806.
For further questions call (508) 382-9555
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.
It has been reported that during use, the spo2 value displayed on the hemo monitor may not update to reflect changes in the patient's oxygen value. it is also possible that if using the pulse rate of the spo2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
Acción
Consignees were e mailed on 5/29/14 a Merge "Important Alert" letter. The letter described the problem and the product involved in the recall. Informed consignees that they had the opportunity to replace the Nellcor SpO2 module with a Masimo SpO2 module free of charge. The letter also provided Clinical Information and the Next Steps to follow. This included to contact Merge Technical Support if they wanted to replace their Nellcor module. For questions, they can contact Lee Harrop, Director Solutions Management, Cardiology, 386-239-2224, Lee.Harrop@Merge.com.
A second letter was sent Sept. 11, 2014 via e-mail. Consignees were made aware of a firmware patch available.