Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The manufacturer identified software related issues. detailed description on the issues is available in the attached letter.
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ncmdr update action :
baxter is sending this communication to announce the release of abacus software version 3.2. baxter will be implementing abacus software version 3.2 at customer facilities as a correction to the issue communicated in our may 7, 2015 safety alert letter, regarding the possibility that the compounder will load the incorrect formula under conditions when two or more different formula files have been created with the same file name.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Manufacturer implements additional and updated warnings and cautions labeling that are not in the patient at-home guide, see attachment.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare corporation is issuing this communication for the colleague pump to remind users to reset the manual tube release (mtr) when it is left in the open position. users that do not follow the labeled instructions for resetting the mtr prior to use will be
unable to power on the device.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
During internal review, it has been identified that a number of prismaflex® control units, sw7.Xx, have been delivered to the customers with incorrect default settings regarding the loudness and pitch for audible alarm signals.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare corporation received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap or missing from the cap. use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the tip of the transfer set, when the patient is not performing a therapy. this may increase the risk of peritonitis.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Risk of air or gas embolism with the inappropriate use (too high pressure, too short distance).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Synovis and baxter healthcare would like to notify you of a communication that is being sent to remind our customers of the approved indications for use for the dura-guard, peri-guard, and vascu-guard products.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: Swissmedic
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare identified that the affected products (self-righting luer slip and luer lock tip caps in the discpac packaging) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare is implementing additional warning label.
specific population using peritoneal dialysis therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. the additional warning identifies symptoms related to unintended increased intraperitoneal volume (iipv) that may result in theses specific populations and provides specific instructions for the patient to follow if increased intraperitoneal volume (iipv) that is suspected.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter ag is initiating a field action in order to update software versions of the prismaflex control unit. baxter has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment.
unloading of the disposable set without following the instructions and warnings on the prismaflex control units may lead to severe blood loss and potentially fatal outcomes.
since 2012, baxter has received reports of six serious injuries and five patient deaths associated with this issue.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
This notice is initiated due to reports of mixing difficulties and high swooshing force (force applied when depressing syringe plunger to homogenize thrombin solution with gelatin matrix). no product defect has been identified.
baxter has decided to provide guidance information to users that should help while preparing the product.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare is sending this communication to inform you of errors found in the arabic version of the instructions for use 'homechoice patient at home guide (pahg)' document number 071964016ara-sa, rev.C. the manual was intended to support saudi arabia's need to provide instructions for use on the following homechoice devices which have been distributed in saudi-arabia:
- product codes r5c8320, 5c4474 - ce marked and for use with 230 v power supply (product code 5c4474 devices manufactured on or after 26 june 2013, serial numbers 650905 and onwards, were no longer ce marked).
- product codes 5c4471, 5c8310 - non-ce marked and for use with 115 v power supply.
the following errors were identified:
1) on the second page, it is not specified which product codes are ce marked and which codes are not.
2) on page 235, under electrical power requirements, the power requirements for the 115v configurations have been omitted. the correct supply voltage is mentioned on the labeling on the dataplate of the device, however, that label is in english and might not be understood by a patient using the device.
3) on the page 235 product codes r5c8320 and 5c8310 were incorrectly listed as "r5c8310" and "5c8320".
a patient/user may erroneously plug a 115v device into a 230v outlet. this may cause the fuse within the homechoice device to blow rendering the device unusable. this may subsequently result in a slight delay in therapy as patients are able to continue therapy with manual supplies. most patients can also contact their pd centers or technical service for a swap within 24 hour.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
May not respond correctly to key pressed on keypad; motors may turn unexpectedly; compounder may stop without alarm and without visible green “complete” light.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter would like to inform you that an error in the sequence of instructions in the direction inserts for the products listed above has been identified. in section 1 (set placement on cycler) under directions for use, step 1.3 instructs users to remove the protector from the patient line connector on the set prior to connecting solution bags. users should not remove the protector from the patient line connector on the set prior to connecting solution bags. the tip protector should be removed from the patient line connector after priming and immediately prior to connecting the patient line to the transfer set, as described in the in the homechoice and homechoice pro apd systems patient at-home guide. exposure of the patient line during setup can lead to touch contamination resulting in the potential for developing peritonitis. baxter is in the process of updating the direction inserts with the correct sequence of instructions.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
An increased device breakage rate for nova t 200 iud was observed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: Swissmedic
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The previous version of easyspray can be turned up to 3.0 bar. since the optimal operating pressure for open surgery ranges from 1.5 – 2.0 bar, the newly developed regulator only allows a maximum pressure of 2.0 bar.
the new duplospray is limited to 1.5 bar to comply with the optimal pressure range for laparoscopic procedures which is from 1.2 – 1.5 bar.
tissomat is no longer sold but installed units are still in use. tissomat units are being replaced by newly developed easyspray.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare corporation is updating the homechoice patient at-home guide addendum to include a discussion of the expected operating sounds associated with all homechoice and homechoice pro devices. the new labeling will address the following: the homechoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the homechoice cycler.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare corporation is providing you with this important information regarding the application software for exactamix compounders’ model numbers 2400-dy and 2400-dx.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter would like to notify you of a recall of the above mentioned product due to the discovery of pinholes defects in the clear bottom film of the packaging.
a potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Baxter healthcare is issuing an urgent device correction for the ak 98 hemodialysis machines listed above. baxter has identified that an incorrect cable was installed in the affected ak 98 machines. the non-compliant cable may cause current leakages higher than specified values if continuously connected to a network during treatment. these units do not have, and are not intended to have, ethernet functionality.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR , FDA
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Bd has confirmed that a limited number of bd max™ systems were manufactured with purchased optical filters that have shown a potential to produce a false positive result for candida glabrata when processing samples positive for trichomonas vaginalis during testing with the bd max™ vaginal panel. if the bd max vaginal panel was successfully verified/validated using the contrived zeptometrix vaginal panel control panel, the risk of reporting a clinical false positive c.Glabrata result is low. the reported c. glabrata false positive results were all identified by customers when using the control material.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
System error may occur under certain circumstances, potentially resulting in interruption of infusion.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Bd is conducting a recall on the above referenced product (1ml & 10ml non-sterile oral syringes) with the specific lot numbers listed. a small percentage of syringes labelled as oral syringes, have a luer tip that has the potential to be inadvertently attached to other luer devices, e.G. i.V. catheters.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Bd has determined that a small number of cartridges from the above referenced product are not sealing properly during pcr testing, this may potentially cause an increase in false results,
indeterminates and/or invalid runs.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Bd has received reports that a small number of products may carry a crack, tear or hole in the clear plastic portion of the unit package leading to a risk of breaching the sterile barrier.