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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Ge healthcare has become aware of a potential safety issue associated with the use of ge centricity laboratory where panel reflex does not occur if dip.Specimen is blank. panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) the ordered panel is a slave panel, and; 2) the panitem specimen group field of one or more of the ordered items on the ma.
Acción
GE Healtchare sent an Urgent Medical Device Correction letter dated March 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers review their workflows to determine whether this series of events could happen at their sites. Customers who self-identified this series of events as a possible workflow are recommended to contact their GE service representative for a software correction. These customers may also elect to identify master panels that may be re-routed ad hoc and then to ensure that the specimen group field is updated to NULL if currently set to blank.
Customers with any questions about this issue are advised to contact their GE service representative or the GE Healthcare IT Help Desk: North America at tgg.nahelpdesk@med.ge.com.
For questions regarding this recall call 847-277-4468.
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
Calculator/data processing module, for clinical use - Product Code JQP
Causa
Ge healthcare is aware of a potential safety issue with the use of ge centricity laboratory instrument interface (if) where free-text sent from im is not being transcribed into free-text in inet. the instrument may upload results to if/inet when order/request is not yet in if/inet. in such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
Acción
GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers. The letter notified customers of the problem, suggested that customers experiencing this problem should retransmit the result from the instrument once the order exists in iNET and verify that the item level free-text is present in iNET, and to contact their GE service representative to request or install the updated software.
Customers with additional questions can contact the GE Healthcare IT Help Desk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com.
For questions regarding this recall call 847-589-8496.
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
Turbidimetric, total protein - Product Code JGQ
Causa
Siemens has confirmed an increase on absorbance errors when calibrating dimension vista urinary/cerebrospinal fluid protein (u cfp) flex reagent cartridge lot 11349 bb.
Acción
The firn, Siemens, sent an "Urgent Medical Device Correction" letter (dated December 2012) was provided to all Dimension Vista (R) UCFP customers who have received UCFP lot 11349BB. The letter described the product, problem and actions to be taken. The customers are instructed to discontinue use and discard any remaining inventory of Dimension Vista UCFP lot 11349BB; provide instructions for product replacement; and complete and return the attacted REQUEST FOR REPLACEMENT FORM via fax to (302) 631-8467. Siemens will replace any un-used inventory of this lot, at no charge.
If you have any questions, please contact your Siemens Technical Solutions Center. your local Siemens Technical Support Representative or 800-441-9250.
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
Couch, radiation therapy, powered - Product Code JAI
Causa
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the robocouch manipulator may be defective.
Acción
Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667
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
Susceptibility test discs, antimicrobial - Product Code JTN
Causa
Use of affected lots may give false indication of susceptibility to nitrofurantoin.
Acción
ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product.
If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
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
Oximeter - Product Code DQA
Causa
Masimo has identified a very small number (0.02%) of rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Acción
Masimo Corporation sent an Urgent Recall Notification letter dated March 8, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer.
1.Customers were instructed to please promptly remove all Rad-8 device(s) from use and your inventory and segregate these devices.
2. Please call 1-800-326-4890 and select option 2 for Technical Services. Determine with Technical Services whether you will return the affected device(s) to Masimo for repair or if eligible, receive a repair kit. If you will return the device(s) for repair, obtain a Return Material Authorization Number (RMA number).
3. Complete the Tracking/Verification Form in Attachment 2 and fax it to Masimo at 1-949-297-7700, even if you do not have or intend to use the affected device(s).
4. If you are eligible and intend to repair units onsite fax the completed original form in Attachment 2 to Masimo at 1-949-297-7700.
5. If you have elected to return the affected device(s), and have an RMA number include the completed original Form in Attachment 2 with the returned device(s) and indicate the RMA number on the outside of the return-shipping box.
We apologize for the inconvenience. Please be assured that Masimo is committed to consistently providing high quality products and services to you, our customers. We thank you for your patience and cooperation while we actively work to resolve this issue.
.
.
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
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Causa
Product may be mislabeled.
Acción
NxStage sent a letter dated March 18, 2013, via email to all consignees instructing them to check their entire inventory and to segregate and quarantine lot F023444 pending further instruction from NxStage.
On 4/2/13 NxStage sent a letter via email to all consignees requesting a return of all RFP-400 and RFP-401 labeled with lot F023444.. Consignees were instructed to complete the recall reply form and provide a list of customers (name address, phone number) and fax them to NXStage Medical, Inc.
Customers with questions were instructed to call 1-866-697-8243.
For questions regarding this recall call 1-866-697-8243.
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.
I-flow initiated two voluntary product removals of the on-q pain relief system: t-block needle/catheter tray and t-block needle/catheter kit because they may have potentially malfunctioned.
Acción
IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the catheter prior to inserting it into the Stingray connector will help with connecting the catheter to the Stingray connector. Customers are instructed that there is no action required for the I Flow ON Q Pain Relief System and ON Q T Bloc. The recall letter is only to provide further instructions on successful set up of the SPIROL catheter with the Stingray Connector included in the ON-Q T-bloc trays. Customers with any questions are instructed to call IFlow Customer service at (800) 448-3569 or IFlow 24 hr Tech support at (800) 444-2728.
On June 1, 2012, an I-Flow sales representative removed the catheters and connectors from the one consignee/customers.
For questions regarding this recall call 949-206-2700.
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.
I-flow initiated two voluntary product removals of the on-q pain relief system: t-block needle/catheter tray and t-block needle/catheter kit because they may have potentially malfunctioned.
Acción
IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the catheter prior to inserting it into the Stingray connector will help with connecting the catheter to the Stingray connector. Customers are instructed that there is no action required for the I Flow ON Q Pain Relief System and ON Q T Bloc. The recall letter is only to provide further instructions on successful set up of the SPIROL catheter with the Stingray Connector included in the ON-Q T-bloc trays. Customers with any questions are instructed to call IFlow Customer service at (800) 448-3569 or IFlow 24 hr Tech support at (800) 444-2728.
On June 1, 2012, an I-Flow sales representative removed the catheters and connectors from the one consignee/customers.
For questions regarding this recall call 949-206-2700.
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
endoscopic irrigation/suction system - Product Code OCX
Causa
The firm was notified by their customers that there was a water leakage from the white tubing connector.
Acción
US Endoscopy Group sent an Urgent Recall Notification letters to their customers. The letter identified the affected product, problem and actions to be taken. They instructed their customers to remove any of the affected products from their inventory and quarantine them. They also requested each customer complete the attached Customer Response Card and return it to US Endoscopy via fax at 1-440-639-4495 or by email at recall@endoscopy.com as soon as possible. For questions contact Customer Service at 1-800-769-8229.
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
Varian has identified an anomaly with the rpm respiratory gating system version i.7.5 with 3d option. while operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
Acción
Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice Letter dated March 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain a copy of this document along with their most current product labeling, advise the appropriate personnel of the content of this letter, and for future reference this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. The letter stated that a Varian Medical Systems has developed a technical correction and a Customer Service representative will contact customers to schedule installation. For question contact your local Varian medical Systems Customer Support District or Regional Manager.
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
Plate, fixation, bone - Product Code HRS
Causa
The synthes one-third tubular dcl plate (11-hole, 1/3 tubular plate w/collar), was released to the united states market in error. this action is not being initiated as a result of adverse events.
Acción
The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual, or reporting one of the following errors during device setup or infusion:
1) cassette check - d;
2) cassette check - p;
3) proximal occlusion;
4) distal occlusion;
5) pressure calibration error;
6) bad pressure sensor event;
7) bad pressure state;
8) distal pressure is out of range;
9) proximal sensor is out of range.
a pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Acción
Hospira sent an Urgent Device Field Correction letter dated March 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter asks that customers immediately perform proximal and distal occlusion tests as defined i nthe GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service and contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM) to report the issue and arrange for the return of the device for recalibration. The letter further reminds customers that the proximal and distal occlusion tests should be performed on an annual basis as a part of the yearly GemStar maintenance schedule. Customers were also requested to complete and return the attached reply form and return it to Hospira by fax to 1-888-714-5077 or by e-mail to Hospira7906@stericycle.com.
Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 800-441-4100.
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.
Vital images, inc. (vital images) received one report about potential user confusion when viewing a brain perfusion scan on vitrea ct brain perfusion 2d when the scan was performed using a wide coverage shuttle acquisition technique. this may result in patient treatment delays, misdiagnosis or mistreatment.
Acción
Consignees were sent on 3/15/2013 a VITAL Images, Inc., "Urgent Field Safety Notice" dated March 15, 2013. The letter described the problem and the product involved in the recall. The letter listed the limitations of the product and the steps to take. Consignees were requested to return the Product Recall Effectiveness Check form. Questions should be directed to Vital Images Customer Support at 1-800-208-3005 or via e-mail, support@vitalimages.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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Pump shutting off during use without warning.
Acción
Hospira sent an Important Device Information letter dated March 18, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the affected product for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leakage, it should immediately be removed from clinical service and Hospira should be contacted at 1-800-441-4100 to arrange for return of the device for repair. If the product has been further distributed they should notify their consignees and confirm they have done so by returning the reply form to Stericycle.
For questions regarding this recall call 224-212-4892.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
Acción
Hospira sent an Urgent Device Field Correction letter dated March 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. Lithium batteries that are older than three (3) years should be replaced. Customers should contact their Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, to determine if their battery need to be replaced and if necessary, arrange for the return of their device to perform battery replacement. Customers with questions should call 1-877-907-7516. For questions regarding this recall call 224-212-4892.
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
Injector and syringe, angiographic - Product Code DXT
Causa
Acist medical systems is issuing a voluntary recall notice for three specific lots of bt2000 automated manifold kits. for these specific lots, acist has received field reports related to ingress of air into the manifold body. this has been detected by the air column detect sensor halting the injection, and normally replacement of the bt2000 automated manifold kit is necessary in order to proceed w.
Acción
ACIST Medical Systems sent an Urgent Medical Device Recall letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to discontinue use or further distribution of the product.
If you possess inventory containing any of the lot numbers listed above, please discontinue use or further distribution of these products. Please return this inventory to ACIST. Upon receipt of the returned BT2000 Automated Manifold Kits, ACIST will arrange for a shipment of replacement kits at no charge. To order additional or immediate replacement product, please contact BRACCO customer service at 1-877-BRACCO9 (1-877-272-2269), option 1.
Please also complete and return the enclosed Medical Device Recall Form (see enclosure). Even if you do not possess any of the affected product in your inventory, the form needs to be completed and returned, indicating that you have no remaining units containing these lot numbers in your inventory.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
During infusions of 2.0 ml/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Acción
Hospira sent an Urgent Device Field Correction letter dated March 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refrain from using the affected produc and contact Hospira at 1-800-441-4100 to arrange for return of their device for repair. Customers were directed to notify their customers if they further distributed the product and confirm they have done so by return of the reply form to Stericycle.
For questions regarding this recall call 224-212-4892.
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 product has a lithium heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Acción
The recalling firm contacted 25 of their 26 customers by phone on February 5, 2013, to notify them of the recall and sent a follow up memo on February 6, 2013, During the call, the firm reminded their customers how many recalled kits they recieved and instructed them to go through the kits and pull the recalled lots. The recalled kits are to be returned to the recalling firm and the firm sent a follow-up memo on February 6, 2013, with the shipping label their customers to place on the returning kit shipping box.
This memo was sent to the customers by overnight Fed-ex mail and the ship label for the returned product was an overnight UPS label. On February 7, 2013, the final customer was notified by phone and instructed to return the recalled kits.
For further questions please call (913) 764-1045.
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
Under certain conditions, photon beams in high energy clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. at maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Acción
Varian sent a Customer Technical Bulletin to all affected customers. The bulletin identified the affected product, problem and actions to be taken. For questions, issues, or concerns contact Varian at 1-888-827-4265 or go to http://my.varian.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.
Unable to pass catheter through outer sheath during embryo transfer.
Acción
The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated March 28, 2013 to its customers. The notification describes the product, problem and actions to be taken. The customers were provided with two options for proceeding: 1) continue to use product if the product passes a pre-test; or 2) return affected product to Smiths Medical for replacement or credit. In addition, the customers were instructed to inspect their inventory and quarantine all affected products; perform a count of affected products currently in inventory; complete and return the attached Confirmation Form via fax to +1-866-258-6068 or email to pamela.harrell@smiths-medical.com; send a copy of this notice to your customers identified having received affected product; and provide email confirmation of your customers notifications to Smiths medical at pamela.harrell@smiths-medical.com. Customers should report any issues with these products to Smiths Medicals Global Complaint Department at +1-866-216-8806 or globalcomplaints@smiths-medical.com.
If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at +1-800-258-5361.
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.
When using the v5m transducer, the display of the temperature on the acuson sc2000 system can be lower than the actual temperature of the v5m transducer. this occurs only if the system hardware contains revision 4 of the mpi board. there is a potential to cause esophageal burns in patients.
Acción
Siemens Medical Solutions USA Inc. sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
A return response form is included for customers to complete and mail to the recalling establishment. Siemens stated additional follow up action will occur, once material is available, where Siemens field service engineers will visit each unit and replace the affected MPI 4 board.
For further questions please call (650) 694-5747.
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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notas adicionales en la data
Pump, Infusion - Product Code FRN
Causa
During infusions of 2.0 ml/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Acción
Hospira sent an Urgent Device Field Correction letter dated March 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refrain from using the affected produc and contact Hospira at 1-800-441-4100 to arrange for return of their device for repair. Customers were directed to notify their customers if they further distributed the product and confirm they have done so by return of the reply form to Stericycle.
For questions regarding this recall call 224-212-4892.
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
Regulator, pressure, gas cylinder - Product Code CAN
Causa
A number of medicyl-e portable oxygen systems may have misapplied valve flow knobs.
Acción
The firm, The Linde Group, sent a "Voluntary Medical Device Recall" letter dated June 21, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to view the enlarged photo on the reverse side of the notice for guidance.
If you or your customers have a Unit with lot number 25/07, then please return it with the Product to your local LifeGas fill center as soon as possible. No other lot numbers are subject to this removal action.
Customers with questions should contact Linde's Customer Care Center at 1-866-LIFEGAS (543-3427).