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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Causa
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
Acción
On February 15, 2017, the firm sent an Urgent Device Correction notification and response form to affected customers via USPS first class mail in order to update software versions of the Prismaflex Control Units. The update was intended to prevent user errors related to the safe unloading of disposable sets. On May 30, 2017, the firm issued an updated notification letter notifying the same customer base of the issue with the programmed syringe sizes. The software update deployed to correct the issue with the safe unloading of disposable sets was also deployed to correct the issue with the programmed syringe sizes. All non-responding customers will be contacted via telephone. Prismaflex control units will be updated to a new software version. For further questions, please call (800) 422-9837.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Firm is initiating voluntary correction of corflo peg with enfit. barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
Acción
Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.
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
Device, iontophoresis, other uses - Product Code EGJ
Causa
The device was reclassified from a class iii device to a class ii device and there are new documentation requirements.
Acción
Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed 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
Device, iontophoresis, other uses - Product Code EGJ
Causa
The device was reclassified from a class iii device to a class ii device and there are new documentation requirements.
Acción
Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed 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
Filler, bone void, calcium compound - Product Code MQV
Causa
Incorrect instructions for use (ifu) included.
Acción
The firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product.
If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: amcconnell@rtix.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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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 contains latex symbol was not printed onto the box label or the sterile (inner) product pouch.
Acción
LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced.
Questions concerning this notice contact 781-221-2266 ext. 183.
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
Counter, differential cell - Product Code GKZ
Causa
The pump relay printed circuit board assembly (pcba) used in the cell-dyn ruby instrument may prematurely fail and lead to instrument stoppage.
Acción
Product correction letters were sent to all affected customers on February 13, 2017 by traceable method. Letters provided information on the reason for the correction with all affected serial numbers listed. Abbott will be contacting each location to schedule replacement of the PCBA Pump Relay Board.
Update: five additional serial numbers were added. Correction letters were sent to new consignees - 3 in Brazil and 2 in Mexico.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Incorrect device was packaged.
Acción
ACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.
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
Impactor - Product Code HWA
Causa
During the turon assembly, the impaction forces caused the polymer, black acetal copolymer from the impaction fixture to wear off on the lateral surface of the humeral stem titanium plasma spray coating.
Acción
There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17.
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 scanner - Product Code KPS
Causa
Four issues:
1. motion controller problem stops scan and no data image produced.
2. door interlock switch problem disables ct scan.
3. detector contacts head holder when performing patient unload.
4. jetstream freezes during gated planar scan.
Acción
Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.
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 scanner - Product Code KPS
Causa
Four issues:
1. motion controller problem stops scan and no data image produced.
2. door interlock switch problem disables ct scan.
3. detector contacts head holder when performing patient unload.
4. jetstream freezes during gated planar scan.
Acción
Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.
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
nuclear medicine diagnostic scanner - Product Code KPS
Causa
Four issues:
1. motion controller problem stops scan and no data image produced.
2. door interlock switch problem disables ct scan.
3. detector contacts head holder when performing patient unload.
4. jetstream freezes during gated planar scan.
Acción
Consignees received a customer information letter via certified mail, 1/31/2017. International consignees were notified by Philips Healthcare Global Market representatives. Field Service Engineers are contacting consignees to conduct appropriate corrections. Non-responders will be contacted multiple times.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Multiple software issues, which may affect the operation and workflow of the system. potential for an apparent delay to testing when these issues occur. the software issues affecting the analyzer may impact all analytes available on the advia centaur xpt system test menu.
Acción
Siemens sent an Urgent Medical Device Correction letter ( UMDC) dated February 2, 2017. An Urgent Field Safety Notice letter ( UFSN) dated February 2017, was also sent to foreign customers.
Customers must follow instructions in the UMDC and UFSN letters. For questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
Beckman coulter is recalling the rack id labels because the rack id number displayed and the rack id barcode label do not match.
Acción
Beckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their
Customer Support Center:
http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada; Outside the United States and Canada, contact their Beckman Coulter 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.
These items are incorrectly etched and labeled. the item etched and labeled as 10mm strut 03.820.350 lot 5919005 is a 12 mm strut. the item etched and labeled as 12 mm strut 03.820.352 lot 5919006 is a 10 mm strut.
Acción
DePuy Synthes mailed an Urgent Notice to customers affected by the issue on 02/13/2017. The reason for the recall was explained, risks associated with the issue were identified, and actions to be taken were addressed. Customers were asked to complete the enclosed Verification form and mail it back to obtain a Return Authorization Number for the product's return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 800-479-6329.
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
Laparoscope, gynecologic (and accessories) - Product Code HET
Causa
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Acción
A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
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
Dna probe, yeast - Product Code MLA
Causa
Bd has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. this issue would result in an invalid test, as described in the package insert.
Acción
Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back.
If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
For further questions please call (410) 316-4428.
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Firm received a complaint of the tip holder breaking during use.
Acción
Manufacturer's Field Safety Corrective Action Report was submitted to ANSM (French Health Products Safety Agency) on January 11, 2017. The Field Safety Notice was sent to U.S. Consignee on January 18, 2017. The letter identified the affected product, problem and actions to be taken.
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
Biopsy needle - Product Code FCG
Causa
Handle may break during use.
Acción
A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
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
Biopsy needle - Product Code FCG
Causa
Handle may break during use.
Acción
A recall was initiated on February 8, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 1856 Corporate Dr. Suite 140 Norcross, GA 30093, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.