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
compressed gas cylinder and valve - Product Code ECX
Causa
Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Acción
The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall.
A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.
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
compressed gas cylinder and valve - Product Code ECX
Causa
Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Acción
The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall.
A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.
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
compressed gas cylinder and valve - Product Code ECX
Causa
Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Acción
The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall.
A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.
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
compressed gas cylinder and valve - Product Code ECX
Causa
Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
Acción
The recalling firm first notified their customers via a letter dated 5/15/09 issued regular mail explaining the reason for recall and requesting the cylinders with specific post valves be returned. A second letter dated 6/1/09 was issued via regular mail which provided specific shipping dates that each customer received the suspect product. Neither of these two letters requested subrecall.
A third letter dated 6/17/09, which included copies of the first two letters, via certified mail. This letter informed the customer the recall was to be conducted to the user level and requested their customer conduct a subrecall. Requested to remove the cylinder from service and call Allied Healthcare Products for return and a replacement at 1-800-268-1661.
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
Tube, gastro-enterostomy - Product Code KGC
Causa
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Acción
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
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
Tube, gastro-enterostomy - Product Code KGC
Causa
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Acción
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
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
Tube, gastro-enterostomy - Product Code KGC
Causa
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Acción
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
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
Tube, gastro-enterostomy - Product Code KGC
Causa
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Acción
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
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
Tube, gastro-enterostomy - Product Code KGC
Causa
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
Acción
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
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
Surgical instrument for pedicle screw system. - Product Code NKB
Causa
The tip of the instrument may fracture during use.
Acción
Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09).
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
in vitro diagnostic - Product Code DHC
Causa
The firm received customer complaints of microbial contamination in positive controls in its anti-cardiolipin igm test kit lot cl-863.
Acción
Bio-Rad initiated its field correction on July 14, 2009. The firm notified domestic consignees by phone followed by fax, and each subsidiary will be given an urgent notice, subsidiary response form, customer medical device correction notification, acknowledgement form and a listing of consignees. The subsidiaries must contact customers as instructed.
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.
User instructions not updated to correspond with product change.
Acción
Instrumentation Industries, Inc. issued a notification letter dated July 9, 2009 to their customers explaining the problem and the need to replace current inventory user instructions with the revised user instructions accompanying the letter.
For further questions, contact Instrumentation Industries, Inc. at 1-800-633-8577.
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.
Biosense webster initiated the recall because of the potential concern with one of the printed circuit board (pcb) components used in the navistar rmt catheters, which may cause the ablation catheter icon to shift on the map viewer when rf energy is being applied. therefore the user, attempting a linear ablation in the location displayed on the carto rmt screen, may ultimately apply rf energy to u.
Acción
The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy."
If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement.
Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.
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
Test, luteinizing hormone (1h), over the counter - Product Code NGE
Causa
The ovulation test strips were shipped without 510(k) premarket notification clearance from the fda.
Acción
Quest Products notified their major customer by telephone and e-mail on 11/7/08, requesting the return of all inventory of the OvuChek Saliva Ovulation Test Strips due to a lack of 510(k) clearance for marketing of the device.
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 - Product Code CBK
Causa
Some servo ventilators 300/300a and servo ventilator 900c/d/e should not be used with a system that may generate negative pressure below -100 cm h2o (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
Acción
Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
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
Accelerator, linear, medical - Product Code IYE
Causa
Potential for improper treatment. a software error may result in potential major underdosing to targeted areas from jaw blockage of the mlc aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).
Acción
Impac Medical Systems Inc sent an Important Safety Notice letter to all affected consginees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Impact Software support as soon as possible if they have the affected configurations identified in the letter. Customers were asked to complete the form included with the letter and and fax to:
European customers: +44 1293 654401
American & rest of world customers 702-992-5002 or e-mail to support@impac.com
Customers were asked to distribute the Safety Notice to any and all users of IMPAC software at their organization who are potentially affected by this issue.
For questions e-mail support@impac.com or call
European customers: 44 1293 654320
American & rest of world customers: 800-488-4672.
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
ultrasound catheter - Product Code DQO
Causa
Screen image quality. an assembly issue on swiftlink connectors may cause reduced/degraded image quality when using acuson acunav ultrasound catheter transducers.
Acción
Siemens Field correction was initiated on 3/20/2009. A device correction letter was distributed to all affected users, with a description of the problem and its corrective actions. Siemens service personnel will make a site visit.
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.
Overheating. a software bug may cause the transducer to overheat when used with certain transducer models. the transducer can become noticeably hot within a few minutes, which may cause patient discomfort or burns.
Acción
The firm, SIEMENS, sent a "Customer Safety Advisory Notification" to its customers on 3/21/2009. The notification described the product, problem and actions to be taken. The customers were instructed to disconnect any transducers that may be in an active transducer port and chose another imaging transducer prior to use of the Aux CW transducer. If they do not have another transducer to select other than those listed in the notification, they should close the study in progress and start a new study before using the Aux CW transducer-this procedure should be followed for each new patient and /or exam type. In addition, the customers were instructed to pass this notice on to all those within their organization who need to be aware of this issue until the corrective action is completed. SIEMENS will release a software update that will correct the issue. The customers local service engineer will install the updates on their system as soon as it becomes available.
Should you have any questions regarding this notification, you may contact your local service support person and/or call (650) 969-9112.
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
in vitro diagnostic - Product Code JJE
Causa
Incorrect result: patient sample bun results reported may be higher or lower than actual level.
Acción
Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.
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 monitor - Product Code CCK
Causa
1) the monitor's ability to withstand electrostatic discharge (esd) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze.
2) the unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.
Acción
Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.
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
VEST 6.6 or earlier software - Product Code LXV
Causa
Marketed without a 510k or pma submission to include the normative data display.
Acción
A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance.
Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.
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
Polypectomy snare for Percutaneous Endoscopic Gastrostomy - Product Code KNT
Causa
Snare can detach in patient. the polypectomy snares and the entake peg system (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
Acción
Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
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
Polypectomy snare for Percutaneous Endoscopic Gastrostomy - Product Code KNT
Causa
Snare can detach in patient. the polypectomy snares and the entake peg system (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
Acción
Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter, percutaneous - Product Code DQY
Causa
Leakage-- due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
Acción
Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra.
For further information, contact Penumbra, Inc. at 1-510-748-3223.
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
Software bug. the cell-dyn emerald wbc l1 flag is configured incorrectly. the flag is not generated according to system requirements.
Acción
Abbott Diagnostics issued a "Product Correction" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions.
For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should contact your local hematology customer support representative.