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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Causa
Lumens may have incorrect lumen size marked on them.
Acción
Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
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
Needle, Fistula - Product Code FIE
Causa
Risk of hubs becoming disconnected from the cannula.
Acción
Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
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
Needle, Fistula - Product Code FIE
Causa
Risk of hubs becoming disconnected from the cannula.
Acción
Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
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
Needle, Fistula - Product Code FIE
Causa
Risk of hubs becoming disconnected from the cannula.
Acción
Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System, Test, Blood Glucose, Over The Counter - Product Code NBW
Causa
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
Acción
A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
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 hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
Acción
Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.
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
Pump, Infusion - Product Code FRN
Causa
The mounting screws of the pole clamp may come loose, allowing the pole clamp assembly to detach from the rear pump housing, if they are not maintained on at least an annual basis.
Acción
Safety Alert letters dated 5/3/05 were sent to all Flo-Gard 6201 and 6301 Volumetric Infusion Pump customers. The letters informed the users of the potential for the pole clamp mounting screws to come loose, and recommended that they inspect the Flo-Gard pole clamp during their routine maintenance or as part of the recommended annual preventative cycle. If the pole clamp appears to be loose, the users were provided with the following steps to be followed to ensure that the pole clamp is properly secured:
a) The recessed area in the housing for the clamp body must be clean.
b) The three mounting screw holes in the housing must not show signs of cracking.
c) The ground wire must be attached to the center screw.
d) The screws must be M4x10 with captive washer.
e) Loctite 425 threadlocker must be applied to each of the three screws.
f) Torque the screws to 7.8 in-lb.
Enclosed was a copy of the Service Bulletin issued in April 2002 with additional information about servicing the Flo-Gard pole clamps.
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
Lancet, Blood - Product Code FMK
Causa
The sterility of the lancets may be compromised due to inadequate packaging seals.
Acción
Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.
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
Lancet, Blood - Product Code FMK
Causa
The sterility of the lancets may be compromised due to inadequate packaging seals.
Acción
Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.
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 inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
Acción
Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.
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
Radioimmunoassay, Human Growth Hormone - Product Code CFL
Causa
Under recovery of diluted samples by as much as 20%.
Acción
Recall letter was sent 5/2/2005 which requests return of the product, a response card was included.
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Nail, Fixation, Bone, Metallic - Product Code NDH
Causa
The gamma nail may have been manufactured with an incorrect lag screw hole angulation.
catalog number 3225-0360s, lot code k949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. catalog number 3220-0320s, lot code k949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
Acción
Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Electrocardiograph - Product Code DPS
Causa
Altitude testing of the advisor with capnography module found the co2 (end tidal and inspired) values are incorrect when the advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). the % co values displayed will be lower than the actual co2 value.
Acción
On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
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
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use - Product Code LXG
Causa
Device does not maintain a uniform internal temperature within 2-8 c at warmer ambient temperatures.
Acción
Recall letters mailed 5/5/2005 request users monitor the temperature variances and evaluate for continued use in thier laboratory.
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
Set, Blood Transfusion - Product Code BRZ
Causa
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
Acción
Hospira sent product recall letters dated 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.