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
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.
During cardiopulmonary bypass (cpb) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
Acción
The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J; affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying 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.
Southmedic has initiated this recall because their japanese distributor received field reports of leaking vapofils. leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. leakage may also expose patients to low concentrations of volatile anesthetics.
Acción
Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic.
U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic.
Consignees were also instructed to immediately notify their customers if they have further distributed these products.
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.
Southmedic has initiated this recall because their japanese distributor received field reports of leaking vapofils. leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. leakage may also expose patients to low concentrations of volatile anesthetics.
Acción
Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic.
U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic.
Consignees were also instructed to immediately notify their customers if they have further distributed these products.
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
Surgical Microscope - Product Code EPT
Causa
Patient burns-the use of the surgical microscope at high light intensity and short working distances can result in patient burns.
Acción
Leica Microsystems faxed a memo entitled 'M520 Heat Issues' to all IMRs on 11/15/05, informing them that the potential to burn exposed patient skin at the closer working distances with the high intensity of light exists with the M520 optics carrier and/or new optichrome light source. The IMRs were sent retrofit packets which consisted of a current User Manual with 'Caution: The light source in this unit may be too bright at shorter focal lengths for surgeon and patient. Please start with light low and turn up till the surgeon has an excellent optical image.'; a sticker reading 'Warning: Maximum Light at Short Distance Can Injure Patient See User Manual', to be placed on the stand near the light intensity controller; a laminated card entitled 'Setting the Illumination Intensity' to be hung on the stand with the enclosed wire tie for in-service training; and a training verification form. The IMRs were instructed to visit each of the end user locations on the enclosed list, installing the stickers, providing the new User Manual and providing the staff that uses the microscope another in-service, stressing the proper use of the illumination system. Upon completion of the in-service, the IMRs will complete the training verification form and have a staff member from the OR sign the form verifying that the warning labels were applied and that the staff was trained, and that the user manual was received. The IMRs will then return the verification form to Leica Microsystems.
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.
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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
Probe, Spatula Electrode - Product Code GCJ
Causa
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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.
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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 Electrode, probe - Product Code GCJ
Causa
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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
Open End Suction/Irrigation Canula - Product Code GCJ
Causa
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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
Flexible Fiber Canula - Product Code GCJ
Causa
There is the possibility of a seal void in the probe plus packaging which may have compromised the sterility of the device.
Acción
The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm.
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
Tube Mount, X-Ray, Diagnostic - Product Code IYB
Causa
Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. risk of injury to operators fingers.
Acción
The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.
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
Retainer Fish - Product Code GZC
Causa
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Acción
On 8/13/04, the firm initiated the recall and its notification was 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.
Notas adicionales en la data
Disposable Surface Electrodes - Product Code GXZ
Causa
The bar electrodes do not meet performance specification for electrode impedance. a manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. these possible lower amplitudes will be measured only if the bar electrode is used as a bar.
Acción
Communication on April 28, 2006 by phone, followed by Certified Mail, with return receipt to confirm receipt of information . The letter describes the issue and asks that affected product be returned. The customer notification allows the user the option of using the Bar Electrode as 2 separate electrodes, as described in the Instructions for Use.
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.