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
Cannula, trocar, ophthalmic - Product Code NGY
Causa
The product has potential to leak beyond their design specification.
Acción
The affected consignees were contacted via letter on 8/11/15 to communicate the potential for leakage.
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.
In certain circumstances involving select da vinci si single-site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Acción
Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures.
2. Replace any instrument that shows signs of damage and contact Intuitive Surgical
Customer Service.
3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using
the instructions provided.
4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual.
If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail:
customersupport-servicesupport@intusurg.com
¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6
PM CET) or ics@intusurg.com
¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
For questions regarding this recall call 408-523-2100.
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
50 trays of dignity low profile ct port were labeled as dignity mid-sized ct port.
Acción
On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
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
Compressor, cardiac, external - Product Code DRM
Causa
Complaints associated with an unexpected stop in autopulse compressions.
Acción
Zoll sent Customer Notification letters dated August 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Zoll Technical Support Line at 1 (800) 348-9011 for further assistance.
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 error: the effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
Acción
The firm, Brainlab AG, sent out a "Field Safety Notice / Product Notification" CAPA-20130417-000315 Brainlab Cranial Navigation System: Effect of setup on overall navigation accuracy for all versions of software on 4/22/2013 and an update on 5/29/2015.
- From April 22, 2013 has been distributed via email to the consignees.
- UPDATE from May 29, 2015 was distributed via email to the medical users.
An active reply by the consignees will be followed, if necessary via further different communication media.
FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the measures described in document Measures to Improve Cranial Navigation Accuracy in the Product Notification letter when using the Brainlab Cranial Navigation System.
Brainlab is requesting that
1. Existing potentially affected customers receive this Product Notification Letter.
2. These customers receive the attached supplement to the Instructions for Use regarding the Brainlab Cranial Navigation System in hardcopy version as an amendment to their current User Manuals. Tentative planned timeline for availability: June 2013
Additionally to advise the appropriate personnel working in your department of the content of Product Notification letter.
If the medical users have the need for further clarification, they are asked to contact their local Brainlab Customer Support Representative.
Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by
E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33
Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
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. the doppler trace measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. the recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead.
Acción
The firm, Hitachi, sent a "DEVICE CORRECTION NOTICE" letter dated April 15, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were inform of the nature of the software error in the Doppler Trace Measurement feature; the circumstances under which this error can occur; and the safety issue involved should incorrect values generated lead to a false diagnosis of stenosis in a patient. The letter provides the customer with a workaround solution in order to avoid this issue. The customer were also instructed to call the HMSA Applications Helpline at 877-871-2777 to reprogram their system to temporarily eliminate the noted safted issue and to immediately have all selections unchecked on the Doppler trace measurement result store setting set up screen. The notification letter also states that Hitachi Medical Systems America (HMSA) will be having their service personnel schedule a visit at each customer location and install a software upgrade on each affected system unit in order to directly address, and permanently resolve this issue.
If you need any further information regarding this notice, please contact the Manager of Regulatory Affairs at 800-800-3106 x3720 or email to: thistlewaited@hitachimed.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 firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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
Replacement, ossicular prosthesis, total - Product Code ETA
Causa
Outer package labels product .75 mm longer than actual size.
Acción
Kurz Medical, Inc. sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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 has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Causa
This recall was initiated due to a customer complaint which reported that while peeling off the tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.
Acción
Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor.
Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor.
For questions customers should contact their local Biomet Contact.
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 recall was initiated because ameditech's internal review of regulatory files found that the two affected lots were manufactured without proper regulatory clearance.
Acción
Ameditech, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer.
The letter requested the customer to:
(1) Cease distribution of the affected lot and provide remaining inventory count to Ameditech.
(2) Destroy any remaining inventory of these lots and document destruction per your site requirements.
(3) Ensure that all users of the device receive a copy of the Urgent Medical Device Recall letter.
A recall verification form was attached to the letter to be completed and returned by the customer via fax at 1-858-677-0243.
Any questions about the information contained in the recall notice should be directed to Ameditech at amd.complaint@alere.com or call 858-535-1968.
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
Screw, fixation, bone - Product Code HWC
Causa
Two lots- one lot of endo-fuse fusion rod, 7x50mm was commingled one lot of endo-fuse(r) fusion rod, 7x70mm. not all parts in each lot are affected. the commingled rod sizes might not be detected prior to surgery.
Acción
The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401.
If you have any questions regarding this matter, please contact 800-874-5630.
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
Screw, fixation, bone - Product Code HWC
Causa
Two lots- one lot of endo-fuse fusion rod, 7x50mm was commingled one lot of endo-fuse(r) fusion rod, 7x70mm. not all parts in each lot are affected. the commingled rod sizes might not be detected prior to surgery.
Acción
The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401.
If you have any questions regarding this matter, please contact 800-874-5630.
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
Intravascular access port - Product Code LJT
Causa
The affected products contain the incorrect winged surecan¿ needle accessory component in certain celsite¿ access port package configurations. the winged surecan¿ needle is used to deliver medications and fluids into implanted celsite¿ access ports.
two winged surecan¿ needle sizes are provided in celsite¿ u.S. package configurations: 20g (pn 4058631) or 22g (pn 16006593a). a 20g or 22g needle.
Acción
B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers.
The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite¿ Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite¿ Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist.
For additional information contact 800 523-9676 x4459.
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.
Quest international recalled their cmv igm test kit because the device failed the test run due to lack of activity in the coated wells.
Acción
On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700. The memo identified the affected product and stated the problem with the device. The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately. Questions should be directed to 305-592-6991.
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
blood parameter monitoring system - Product Code DRY
Causa
Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient.
the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
Acción
Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
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
blood parameter monitoring system - Product Code DRY
Causa
Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient.
the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
Acción
Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
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
Stains, hematology - Product Code KQC
Causa
Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
Acción
EMD Chemicals Inc. sent an "IMPORTANT PRODUCT RECALL" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. An attached response form is included for customers to complete and return via fax to EMD Chemicals at 856-423-6314. Any questions concerning this recall notice should be directed to EMD Chemicals Technical Service Department at 1-800-222-0342.