U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Counter, Differential Cell - Product Code GKZ
Causa
The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (hgb) test results.
Acción
On September 20, 2005, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the recall.
In February, the firm expanded its recall to all lots as a result of having identified an additional failure in a different lot.
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.
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Acción
On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.
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.
In 2001, separate reports of mild shock, sparking and smoke from accumetrics pn 29001 power supply.
Acción
Letters and replacement power supplies were sent to consignees by Fedex, 2-day with proof of delivery. End-user customers were instructed to return the affected power supply to Accumetrics, using the provided pre-paid shipping carton.
Consignees who do not return the power supply within two weeks of the notification will be contacted by phone to assess compliance with the recall and to determine the status of the product at the site.
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.
It was found during a study, arcing might occur in the transformer of the high voltage generator, xtp-8100g and xtbp-8100g displaying an error message and interrupting fluoroscopy.
Acción
Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
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
Introducer, Catheter - Product Code DYB
Causa
A lot of product contains a 6f obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. the obturator is correctly sized (6f) per the labeling on both the sterile bag and shelf carton.
Acción
A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.
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.
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.
Instructions for use are not adhering to the product.
Acción
Recalling firm issued recall letters dated October 5, 2005 informing the hospitals of the problem and that firm representatives would contact them to visit their facilities to affix new labels.
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.
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-lead ecg data.
Acción
Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.
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.
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-lead ecg data.
Acción
Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.
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
unknown device name - Product Code ZZZ
Causa
X-ray leakage exceed exposure standard of 0.5 mr/hr.
Acción
On 10/7/05, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the Corrective Action Plan (CAP). The changes will be completed on each CTX 5500/2500 at the next scheduled monthly maintenance visit by InVision Field Service Engineer.
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.
A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
Acción
Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.
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.
A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
Acción
Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.
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.
A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
Acción
Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.
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
General Surgery Tray - Product Code LRO
Causa
The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex.
Acción
Cardinal Health notified the accounts who ordered the affected packs via letter dated 10/3/05, informing them that the packs that were labeled latex-free actually contained an elastic bandage that contained latex rubber. The letters were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to telephone Cardinal Customer Service at 1-800-964-5227 for return instructions for the affected packs return to Cardinal Health 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
System, Monitoring, Perinatal - Product Code HGM
Causa
Potential for incorrect weight to be displayed.
Acción
On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.
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
Wheelchair, Powered - Product Code ITI
Causa
When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
Acción
The recalling firm sent letters to all consignees.
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
The product is labelled as containing a 4f catheter when the trays/kits actually contain a 5f catheter. the catheters will not fit into the sheath-dilator that was included in the tray.
mislabeled as 4f.
Acción
On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
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
The product is labelled as containing a 4f catheter when the trays/kits actually contain a 5f catheter. the catheters will not fit into the sheath-dilator that was included in the tray.
mislabeled as 4f.
Acción
On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Test, Time, Partial Thromboplastin - Product Code GGW
Causa
Prolonged aptt results.
Acción
The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
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.
Omron is recalling the omron 3-way instant thermometers due to possible overheating of the probe tip.
Acción
Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert consumers who may have purchased the thermometer at a retail pharmacy, and has posted both the press release and the recall letter on their website at www.omronhealthcare.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.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
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.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
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.
Vendor-supplied memory chip in a limited number of st. jude medical icds can trigger a temporary loss of pacing function and permanent los of defibrillation support.
Acción
Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.
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, X-Ray, Tomography, Computed - Product Code JAK
Causa
Overhead system can fall due to the failure of a retaining ring.
Acción
The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/7/05 to all customers. The notice informs customers of the problem and cautions anyone to be under the system when in use. The notice also informs the customer that a firm representative will schedule a time to perform the upgrade. On 10/13/05, the recalling firm also issued a notification to scanner manufacturers alerting them of the problem.
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
Dna-Probe, Human Chromosome - Product Code MAO
Causa
The dna-probe has a target size of ~300 kb region instead of the labeled ~190 kb region.
Acción
Abbott Molecular sent letters dated October 2005 to their direct laboratory accounts on 10/28/05 via first class certified mail. The accounts were informed of the discrepancy between the actual size and region of coverage produced by the affected lots and that described in the product literature. The accounts were instructed to assess the impact of this discrepancy on the use of the product in their laboratory and to retain a copy of the letter with any of the affected product remaining in their inventory.