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
Ceiling Mounted Surgical Light - Product Code FSY
Causa
Installation records are incomplete.
Acción
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.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
Ceiling Mounted Surgical Light - Product Code FSY
Causa
Installation records are incomplete.
Acción
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.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
General & Plastic Surgery Laparoscope - Product Code GCJ
Causa
Installation records are incomplete.
Acción
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.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
General & Plastic Surgery Laparoscope - Product Code GCJ
Causa
Installation records are incomplete.
Acción
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.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
Anesthesia Cabinet, Table, or Tray - Product Code BRY
Causa
Installation records are incomplete.
Acción
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.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.
Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
Acción
St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm.
For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.
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
ventilator, continuous, facility use - Product Code CBK
Causa
The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on printed circuit board (pcb) 2104a in the newport e360
ventilator. ventilators manufactured between september and december 2009 are
affected by this field correction. all affected ventilators require the replacement of the pcb2104a board to avoid early failure of t.
Acción
The firm, Newport Medical, sent a "Field Correction Notice" dated April 14, 2010, to all customers. The notice describes the product, problem and actions to be taken by the customers. The customers were instructed to:
1) provide your affected customers with a copy of this letter and advise them to pay close attention to pressure errors which can be an early warning sign of the pressure transducer failure;
2) Schedule their ventilators for replacement of the PCB2104A board as quickly as possible to avoid any unanticipated disruption in their use of their product;
3) Contact our Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers) to request the replacement kits you will need; and
4) Complete the attached form and return it to Newport Medical as you complete your PCB2104A replacements. This will allow us to ensure that all affected ventilators have been addressed and close this field action.
For questions, customers were instructed to contact Newport Medical Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
electrode, electrocardiograph - Product Code DRX
Causa
Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. the user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.
Acción
The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.
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
Tap, bone - Product Code HWX
Causa
Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
Acción
Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.
For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
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
Tap, bone - Product Code HWX
Causa
Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
Acción
Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.
For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
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
Tap, bone - Product Code HWX
Causa
Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
Acción
Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.
For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
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
Tap, bone - Product Code HWX
Causa
Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
Acción
Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.
For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
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
Tap, bone - Product Code HWX
Causa
Certain lots of the non-cannulated modular bone taps used with the firebird spinal fixation systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
Acción
Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm.
For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
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.
Cml, inc. was notified by a-m systems in a letter dated march 31, 2010 that they were recalling a component of their xenon kit (viromax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.
Acción
The firm, A-M Systems, sent two "URGENT: Notification of Product Recall/Correction" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers.
Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: rthompson@a-msystems.com with any questions, comments or concerns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
Heater, breathing system w/wo controller (not humidifier or nebulizer - Product Code BZE
Causa
The y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. this leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Acción
The firm, CareFusion, sent an "URGENT RECALL NOTICE" dated May 29, 2012 to all of the affected customers on the same date via registered return receipt mail. The notice described the product, problem and actions to be taken. The customers were instructed to immediately destroy any affected product in-stock at their facility and to NOT further distribute these products.
NOTE: The notice stated "Carefusion is removing from the the market all lot numbers less than lot #0000414257 or begin with the letter 'Y' for all Infant Breathing Circuit product codes listed in the provided attachment".
The customers were also instructed to not return the product to Carefusion. Return the product directly to: Owens and Minor Health Care Logistics at 1651 California Street, Suite C, Redlands, CA 92374, Attn: Recall Coordinator, for immediate replacement.
NOTE: The notice the stated "Failure to follow these important measures may result in a potential patient safety risk".
In addition, the customers were instructed to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk, advising them to discard or return any CareFusion AirLife Infant Breathing Circuits with the noted product/lot numbers for replacement; and to complete and return a enclosed reply form indicating the amount of inventory in stock, amount destroyed and amount returned.
The distributors were requested to complete and return the attached Acknowledgement Form indicating that they have received the recall notice and that they communicated the Recall Notice to all customers who have purchased the affected breathing circuits via Fax to (847) 473-7774 or email to David.Wehrheim@Carefusion.com. They were also instructed to contact CareFusion Channel Management at (866) 802-6320 for further details on return and/or replacement of stock.
If you have any questions related to this information, please call (847) 473-7495 or email David.Wehrheim@Caref
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Template - Product Code HWT
Causa
The trial stems were manufactured using the wrong design.
Acción
The firm notified their consignees of their product recall by parcel post on 07/16/2013.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.
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
compression wrap - Product Code MDR
Causa
Some systems in these lots have built-in pressure system lines with the incorrect amount of spacing. some systems in these lots had i inch space between each line with no tension applied. the system should have 1.25 inches of space. the correct spacing (1.25") is necessary to achieve the measured tension ranges. the incorrect spacing may result in the inability to achieve the correct tension level.
Acción
CircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided.
this listing for product returns.