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 delfia hfsh kit lot failed real time stability testing. the real time stability data demonstrated a decrease in hfsh concentrations between -4.8% to -11.3% for control sera. the -11.3% bias was observed at an hfsh target concentration of 101 iu/l. the change observed in the serum samples within the range 1.76 67.0 iu/l hfsh averaged -2.9%. the reference range of the assay spans 0.60 to 98.0 iu/l.
Acción
PerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions.
Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.
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
Cardiac c-reactive protein, antigen, antiserum, and control - Product Code NQD
Causa
Tina-quant cardiac c-reactive protein (latex) high sensitive (crphs) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/l on the modular analytics p module.
this issue can lead to erroneous low crphs results. crphs is used as a marker for the prediction of cardiovascular risk. an erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.
Acción
Roche Diagnostics sent a Reagent Bulletin dated February 26, 2016, to all affected consignees. The recall notifications included a description of the reason for the recall, affected product, request for replacement, and consignee responsibilities; the notification did not include instructions for responding to the recall notification.
Actions Required
" Do not use CRPHS lot number 604450. If you have any affected product in your inventory, discard it per local guidelines.
" Complete the attached replacement request form to receive replacement product.
" File this Reagent Bulletin for future reference.
Questions
Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this Reagent Bulletin.
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.
Cut lines on the image may present horizontally rather than vertically.
Acción
MERGE sent an Urgent Medical Device Recall dated March 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Merge Healthcare is working on correcting the issues and will inform customers once a fix is made available. Customers were asked to reply using the enclosed form and the return addressed envelope. If customers have further distributed the affected product they need to identify their customers and notify them at once of the product recall. Customers with questions were instructed to send an email to recall@merge.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
Bottle, collection, vacuum - Product Code KDQ
Causa
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Acción
Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode.
Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590.
Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
UPDATE:
On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
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
Sealant, pit and fissure, and conditioner - Product Code EBC
Causa
There was a labeling error with product, ultraseal xt plus clear refill, part number (pn) 565, lot number (lot) bd79t. the package was mislabeled as pq1, pn 641; while the barcode, ifu and products were labeled for ultraseal xt plus clear refill, pn 565, lot bd79t.
Acción
Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.
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
Bottle, collection, vacuum - Product Code KDQ
Causa
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Acción
Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode.
Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590.
Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
UPDATE:
On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
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
Apparatus, autotransfusion - Product Code CAC
Causa
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Acción
Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode.
Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590.
Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
UPDATE:
On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
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
Apparatus, autotransfusion - Product Code CAC
Causa
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Acción
Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode.
Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590.
Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
UPDATE:
On 1/16/17, Maquet issued recall letters that identified correct lot numbers and products in the letter titles: UPDATE-UPDATED AFFECTED DEVICES. Two letters issued one to customers who received the Dec 23 letter and one to new customers who who did not receive the Dec. 23 letter.
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.
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Acción
MERGE sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. Non-responders were issued a second letter dated July 11, 2016, The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to reply using the enclosed form and the return addressed envelope and also to ensure that all users of the product were provided with the notification. If product was further distributed, customer were asked to identify their customers and notify them at once of the product recall. Customers with questions were advised to email recall@merge.com.
For questions regarding this recall call 877-741-5369.
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 size 4 empowr baseplate was mislabeled as a size 6. the affected lot was laser marked as m6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Acción
The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.
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
Insufflator, laparoscopic - Product Code HIF
Causa
Device could cause a patient overpressure situation without any visual or auditory indication or warning.
Acción
Northgate Technologies sent an Urgent Medical Device Recall Notification letter dated November 17, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to examine their records and ascertain the location of affected devices, cease distribution or use and quarantine those products appropriately. Ship all affected products in their possession to Northgate Technologies, Inc., 1591 Scottsdale Court, Elgin, IL 60123. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 847-608-9405. If product was further distributed, those customers should be notified immediately. Customers with questions should call 224-856-2253. For questions regarding this recall call 800-348-0424.
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.
Contours are not handled correctly if the ct dataset contains slices with dicom z coordinates of xx.X50mm.
Acción
Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned.
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
Control, hemoglobin, abnormal - Product Code JCM
Causa
The device defect associated with this recall may result in hba1c values with a negative bias in patients with the hemoglobin variants c, d, e and s. the negative bias occurs at the higher levels of hba1c, e.G. 9%, but not at the diagnostic medical decision point of 6.5%.
Acción
Recall notification letters were distributed to customers on 11/7/16. The letters instructed customers to review the chormatography to determine whether or not a variant peak was detected. If so, restest the sample using an alternative method.
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.
Software anomaly; an issue was found with the proton pencil beam scanning (pbs) dose calculation in raystation 4.0, 4.5, 4.7 and 5.0. for treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
Acción
Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).
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
Staple, removable (skin) - Product Code GDT
Causa
Sterility deficiency: the packages are not sealed properly and thus the sterility is not assured.
Acción
The firm, Telexflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/18/2016 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any affected products; complete and return the Recall Acknowledgement Form by fax to 1-855-419-8507, Attn: Customer Service or email to: recalls@teleflex.com (even if you do not have any affected product) and return the product with the completed Recall Acknowledgement Form. A customer service representative will contact you with a RGA # and provide instructions for the return of the product.
If you have any other questions, feel free to contact your local sales
representative or Customer Service at 1-866-246-6990.
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.
Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
Acción
Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).
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 - Product Code FRN
Causa
Bayer has determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted.
Acción
Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, opt 2.
For questions regarding this recall call 412-767-2400.
On December 5, 2016, the recalling firm sent a new letter indicating the inline filter has been successfully tested and that they have qualified a compatible in-line filter to be used with the Patient Administrative Set (PAS) that will allow you to resume use of your Intego 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.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Smiths medical became aware that three (3) lots of acuvance2 safety catheter, product number 1720-ai, contain devices with missing or incorrectly positioned side port valves.
Acción
Consignees were sent on 11/21/2016 a Smiths Medical "Urgent Medical Device Field Safety Notice: dated November 18, 2016. The letter was addressed to "Clinician who uses the Acuvance¿2 Safety Catheter". The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to complete and return the "Urgent Medical Device Field Safety Notice Response Form" within 10 days of receipt. For questions contact Stericycle via email at the smithsmedicalrecall@stericycle.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.
Customer complaint was received relating to a lifepak15 device that would power on then power down unexpectedly after a short period of use. when the lp15 powered down, power could be immediately restored by activation of the power button. the device was connected to a cellular modem from multitech systems for use with life net services. the corrective action was completed by velocitor solutions in december 2010.
Acción
Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.
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.
Covidien issued a labeling update for the covidien devon light gloves. busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Acción
Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.
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
Tray, biopsy, without biopsy instruments - Product Code FCH
Causa
Covidien issued a labeling update for the covidien devon light gloves. busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Acción
Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.
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
Tray, surgical, instrument - Product Code FSM
Causa
Covidien issued a labeling update for the covidien devon light gloves. busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Acción
Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.
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 firm received complaints of cracks in the weld on the head of the mallet. in the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
Acción
Smith and Nephew sent an Urgent - Product Recall 1 st Notification dated November 16, 2016, to all affected customers.
Actions for Hospital Representatives:
1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately.
2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities
that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form.
3. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.
Actions for Smith & Nephew Affiliates/Distributors
1.Send this letter to your customers and ask them to return the recalled product.
2. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately.
3. Complete the last two columns in the Inventory Return Certification Form above, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return . Include your contact information in the spaces provided at the bottom of the form.
4. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
5. Return any affected product
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
A software defect is causing issues with the iqon spectral ct and philips spectral ct applications while filming, saving and annotating images.
Acción
A Field Safety Notice (Attachment #1 Field Safety Notice FSN 16-061-72800659 and FSN 88100051), will be sent to US consignees via certified mail. Philips Key Market representatives will distribute the notice internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
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
A software defect is causing issues with the iqon spectral ct and philips spectral ct applications while filming, saving and annotating images.
Acción
A Field Safety Notice (Attachment #1 Field Safety Notice FSN 16-061-72800659 and FSN 88100051), will be sent to US consignees via certified mail. Philips Key Market representatives will distribute the notice internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.