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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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 real-time numeric value for ventricular end-diastolic pressure (edp) displayed on the live display may be inaccurate. because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the fc2010 device, the fc2020 device, which is used in the pre or post-op holding areas, is not impacted by this issue.
Acción
The firm initiated their recall by letter on March 14, 2018. The Field Safety Notice informed the consignee about:
" what the problem is and under what circumstances it can occur
" the actions that should be taken by the customer / user in order to prevent risks for patients
" the actions planned by Philips to correct the problem.
If further information or support concerning this problem is needed, the consignee was directed contact the local Philips representative: 800-669-1328 option 2, then option 3.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Causa
Potential for capio sutures to break and /or detach.
Acción
Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative.
**No product is being recalled and you are not required to return product to Boston Scientific**
There is no impact to previously implanted mesh devices.
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
unknown device name - Product Code N/A
Causa
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Acción
On February 2, 2018, the firm issued an Urgent Medical Device Correction notification to their distributors to make them aware of the device correction. The firm requested that distributors further disseminate an attached recall letter to consignees.
The communication addressed to consignees advised of the issue affecting the device. Consignees were asked to inform users that the device is for armboard use only, and not to be used with the product system's leg support. The notice informed consignees that the firm would provide new units upon completion of development along with revised Instructions for Use.
Customers with questions concerning this Urgent Medical Device Correction were referred to Allen Medical Customer Service: (800) 433-5774, 8:30AM-5PM (EST)
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.
This device was mislabeled and is not the correct component for this patient.
Acción
TMJ Concepts sent an Medical Device Recall Communication letter dated March 12, 2018.
INSTRUCTIONS:
The implants for this case should not be used and should be immediately quarantined. We request that you return the entire case (the anatomical bone model together with both the fossa and mandibular components) to us by FedEx Priority Overnight Delivery. Any bone screws and drills that were provided with the shipment can be retained at your hospital and do not need to be returned. For further questions, please call (805) 650-3391.
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 cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Acción
An Urgent - Medical Device Recall letter, dated January 31, 2018, was sent to the impacted customers on 02/01/2018. The letter identified the affected device and the reason for the recall. Customers were instructed to immediately cease using the recalled product and return unused products to Keystone Dental. Customer Relations Reply Forms are being utilized to document the communication. Completed Relations Reply Forms should be faxed/ emailed to Customer Support; 866-903-9272 or customersupport@keystonedental.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
Stain, fetal hemoglobin - Product Code GHQ
Causa
Three lots of human fetal hemoglobin fitc conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.E. false positives).
Acción
All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure.
The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions.
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.
There is a possibility of low volume and/or leaking standard bottles.
Acción
Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.
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.
Inaccurrate flow readings. depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a flow probe relocation or manipulation).
Acción
The firm notified customers via phone alerting them of this affected device, issue, potential hazard, correction, and instructions. The communication also included scheduling an expedited service call for a Field Service Technician to replace the affected Flowmeter Module with a corrected Flowmeter Module. When necessary to avoid delaying or cancelling life-sustaining surgery, users can continue to use the Flowmeter Module while awaiting replacement. Once the issue is recognized by the user, if a replacement Flowmeter Module is available, replacement and reassignment of safety connections of the Flowmeter Module can be accomplished in less than 15 seconds. In the event that a replacement Flowmeter Module is not available, a less common mitigation is the use of a back-up stand-alone centrifugal pump or a stand-alone ultrasonic flowmeter system to provide flow data. Customers should receive a copy of the Urgent Medical Device Recall phone script by e-mail along with a Customer Response Form. The e-mail should be reviewed, and the form completed and returned as indicated. Questions or concerns can be directed Terumo CVS Customer Service at 1-800-521-2818.
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 recalling firm identified a software issue related to the patient line check (plc) which may result in an increased risk of overfill (also known as increased intraperitoneal volume, iipv). overfill/iipv may result in serious injury or death.
Acción
On 01/25/2018, the recalling firm sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk.
On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning.
Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times.
The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.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.
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Acción
A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.
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.
Certain flex connectors supplied with halyard closed suction kits with flex connector may become loose or disconnect before use or during use.
Acción
Customers were notified via mail and/or email on about 02/07/2018. Instructions for distributors included to notify all affected customers who may have received potentially impacted products and to complete and return the Distributor Acknowledgement Form.
Instructions for customers included to ensure adequate connection of the Flex Connector to Swivel Connector before use of the product by following. This accomplished by ensuring a tight fit is achieved on the Swivel with the Flex Connector advanced approximately three-quarters over the Swivel, so a gap remains visible. If and adequate connection is observed, the Flex Connector may be replaced with a new, sterile Flex Connector and the system connection should be re-evaluated. Lastly, if use of a Flex Connector with the ventilator circuit is optional, the closed suction Swivel Connector can be connected directly to the ventilator circuit. During use, if a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector (e.g. HYH Product # 1115) and ensure adequate connection as described in this notice. If an inadequate connection occurs, Halyard Health instructs customers to safe the Flex Connector and report it via the Product Complaint Process (PIQ) and the local Halyard Health Sales Representative will assist.
Additionally customers were instructed to complete and return the Acknowledgement Form and distribute the recall notice to all clinicians in the facility that may be impacted.
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 kits may produce an elevated rate of false positive calls for the staphylococcus aureus identification probe (sau).
Acción
The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.
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.
Certain flex connectors supplied with halyard closed suction kits with flex connector may become loose or disconnect before use or during use.
Acción
Customers were notified via mail and/or email on about 02/07/2018. Instructions for distributors included to notify all affected customers who may have received potentially impacted products and to complete and return the Distributor Acknowledgement Form.
Instructions for customers included to ensure adequate connection of the Flex Connector to Swivel Connector before use of the product by following. This accomplished by ensuring a tight fit is achieved on the Swivel with the Flex Connector advanced approximately three-quarters over the Swivel, so a gap remains visible. If and adequate connection is observed, the Flex Connector may be replaced with a new, sterile Flex Connector and the system connection should be re-evaluated. Lastly, if use of a Flex Connector with the ventilator circuit is optional, the closed suction Swivel Connector can be connected directly to the ventilator circuit. During use, if a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector (e.g. HYH Product # 1115) and ensure adequate connection as described in this notice. If an inadequate connection occurs, Halyard Health instructs customers to safe the Flex Connector and report it via the Product Complaint Process (PIQ) and the local Halyard Health Sales Representative will assist.
Additionally customers were instructed to complete and return the Acknowledgement Form and distribute the recall notice to all clinicians in the facility that may be impacted.
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
Lift, patient, non-ac-powered - Product Code FSA
Causa
Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.
Acción
Autochair will issue a Retrofit Failsafe Kit. In the meantime, please quarantine current stock of SmartBase products until the failsafe device has been fitted and tested.
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
Stretcher, wheeled - Product Code FPO
Causa
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
Acción
On February 27, 2018, affected customers received an Urgent Medical Device Correction Notification via FedEx notifying them of the issue and potential hazard. For distributed units, the four Floor Plate Attachment Brackets that hold the anchor in place will be replaced in the field by Strykers field service personnel. Customers will be asked to return a business reply form to acknowledge that they have received and understand the notification. For further questions, please call (269) 389-8306.
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 potential risk of unnecessary radiation exposure due to a software issue.
Acción
Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
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
Bandage, cast - Product Code ITG
Causa
A quarantined lot of the devices was released for sale. devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Acción
On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.
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
Disinfector, medical devices - Product Code MEC
Causa
There is potential for a cart with disinfected goods to unload without the trolley being docked. disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
Acción
A letter (Urgent Medical Device Recall Notice) was issued March 2, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if device is still in use at the facility. The letter instructs the customer to contact Getinge Service to schedule a visit and service by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and perform the correction when affected installed devices are identified.
Recalled product will be corrected by a trained Getinge Service Representative. The correction will involve a software update to remove any risk to operators. Additionally a
preventive hardware update that provides a longer wearing end stop pin will be performed during the field correction. For further questions please call (585) 214-6049.
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.
Teleflex medical is recalling the affected product because there may be missing or incomplete information on the package label.
Acción
The recall notice was disseminated by letter on 03/19/2018. The letter stated the following:
"1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter."