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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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 KOG
Causa
Large product label contains an incorrect expiration date.
Acción
Consignees were notified by letter (USPS certified)on/about April 21, 2006.
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
Embolic Protection System - Product Code NFA
Causa
Alarm activiation-a priming issue involving the flow control unit due to a software problem has caused false postive extraction line block (elb) alarming. use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.
Acción
The recalling firm issued a draft recall letter to their European distributor who translated the letter for 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.
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.
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.
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 Introducer - Product Code DYB
Causa
St jude medical has determined that a limited number of agilis steerable introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. the risks that exist are related to the loss of hemostasis through the agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.
Acción
A Field Action Notification, dated 04/13/06, was sent to hospital's Electrophysiology labs (cath labs) and to physicians. This Notification describes the issue, the risk to patient, identifies lot numbers of product affected and states that a SJM Rep will be contacting them soon. The SJM Reps visited the hospitals to verify they received the notification and retrieve affected product. Replacement product will be provided at no charge. EXPANDED RECALL A Field Action Notification, dated 06/01/06, was sent to hospital's Electrophysiology labs (cath labs) and to the physicians who reported a problem with the device. This Notification describes the issue, risk to patients, identifies lot numbers and states that a SJM Representative will be contacting them soon to facilitate the return of product. Replacement product will be offered at no charge. The physician notification, dated 06/01/2006, describes the issue, the risk, lot number affected and informs them that a notification has been sent to the hospitals EP Lab.
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, Continuous Flush - Product Code KRA
Causa
During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
Acción
On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.
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.
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
Polymer Ligating Clips - Product Code FZP
Causa
The hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
Acción
Teleflex Medical sent Important Product Safety Information letters dated 4/18/06 to all of their customers who have purchased Hem-o-lok Ligating Clips from Teleflex. The letters informed the healthcare providers that Teleflex has been made aware of incidents in which the ligating clips (sizes L and XL) were reported to have become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Although none of the incidents appear to have involved any defect in or malfunction of the ligating clips, misapplication of the Hem-o-lok clips during such laparascopic procedures may not immediately be apparent and can have serious, even life-threatening consequences post-operatively. Therefore, Teleflex has added the following contraindication to the Instructions for Use accompanying the Hem-o-lok Polymer Ligating Clips: 'Contraindications': Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic nephrectomies in living donor patients. 'Caution': The clip must be latched to ensure proper ligation of the vessel or tissue. Inspect the ligation site after application to ensure proper closure of the clip. Security of the closure should be confirmed after ligation. The Hem-o-lok Polymer Ligating Clip is not designed for use as a tissue marker. Weck recommends that more than one clip be used to ligate the renal artery in procedures other than laparoscopic donor nephrectomy (see Contraindication, above). Application of more than one clip to all other vessels should be left to the surgeon's judgment.' Any questions concerning the letter were directed to Teleflex Medical at 800-334-9751, option #7, then option #5.
Teleflex sent follow-up ¿Important Product Correction Notice¿ letters dated 8/2/06 to all of their Hem-o-lok Ligating Clips customers via registered mail on 8/7/06. The letters provide clarification of the 4/18/06 letter, reinforcing that the clips are contraindicated for use in ligating t
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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, Percutaneous - Product Code DQY
Causa
Potential for non-sterility due to loss of package integrity.
Acción
Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.