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
Infusion set - Product Code LZG
Causa
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia.
Acción
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
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
Infusion set - Product Code LZG
Causa
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia.
Acción
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
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
Infusion set - Product Code LZG
Causa
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia.
Acción
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
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
Infusion set - Product Code LZG
Causa
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia.
Acción
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
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
Intermittent infusion pump - Product Code FRN
Causa
Intermittent infusion pump may continually dispense medication under certain conditions.
Acción
All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification
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
Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the his system software. the specimen heading "j" was removed and the diagnosis appeared under the specimen heading "i" as a result the specimen with the heading "i" had two diagnosis.
Acción
Software corrections were sent as of 10/30/2003 for clients to upgrade to, the correction software patch is in versions 3.17.5.16, 3.17.6.10, 3.17.7.3 and 4.1.1.0. The firm did not inform the non-affected consignees of the failure because the firm concluded that the associated risk was low.
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
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
Acción
Consignees were notified of recall and provided with a software correction patch ICC number 3618.
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
pathology lab software - Product Code JQP
Causa
The client had made a decision to use the softpath module in a nonstandard manner. under specific circumstances, incorrect text may appear on a patient report.
Acción
The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
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
Detector And Alarm, Arrhythmia - Product Code DSI
Causa
Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
Acción
On May 5, 2006 a letter was issued to all consignees, via return receipt requested. The letter advised consignees of the issue and provided some ways to mitigate the risk. Anyone experiencing the anomaly is to document the failure and report it to the firm. A field service representative will visit each consignee to optimize the antenna system to reduce intermodulations. After determining the root cause and validating a fix, the firm issued a second letter dated August 21, 2006 to their consignees. The letter advised consignees of three issues that needed 'improvement' and stated a service engieneer will schedule a time to visit and install the improvements.
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
Medical Image Analyzer - Product Code MYN
Causa
The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). the product is approved to have a sensitivity of 63.3% and a specificity of 5.0. thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
Acción
The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.
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
Medical Image Analyzer - Product Code MYN
Causa
The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). the product is approved to have a sensitivity of 63.3% and a specificity of 5.0. thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
Acción
The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.
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.
Gyrus acmi has identified a product issue wherein their plasmaseal open forceps, models 2103pk and 917015pk, may not deliver adequate hemostasis during use. although gyrus acmi has had no reports of serious injury to patient, testing indicated that the possibility exists.
Acción
US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.
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
Blood Glucose Meter - Product Code NBW
Causa
The products may encounter display problem, 'er 4' message, during prolonged use when the low battery symbol is displayed. the situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
Acción
On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
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
Dislodger, Stone, Biliary - Product Code LQR
Causa
Lack of assurance of sterility, as the sterile barrier may fail.
Acción
Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.
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
Blood Glucose Meter - Product Code NBW
Causa
The products may encounter display problem, 'er 4' message, during prolonged use when the low battery symbol is displayed. the situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
Acción
On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
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
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
venous access system - Product Code FOZ
Causa
The 9f device may contain a 10 f sheath instead of the 9f.
Acción
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
Acción
Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code CJE
Causa
The reagent may be contaminated with microorganisms.
Acción
Consignees were notified via recall letter dated 6/9/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
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
Cholesterol Reagent Set - Product Code CCH
Causa
Unexpected changes in qc and proficiency results due to qc and proficiency material matrix.
Acción
Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
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 CFR
Causa
Product does not meet performance specifications through its labeled expiration period.
Acción
Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.