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 tracheostomy and tube cuff - Product Code JOH
Causa
Covidien is recalling certain cuffed shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
Acción
Covidien sent an Urgent Medical Device Recall letter dated July 18, 2012 to all affected consignees via mail (FedEx) notification. The customer communication identified the affected product , problem and actions to be taken. Customers were instructed to examine their inventory, segregate product with the identified affected product codes and lot numbers and complete the enclosed verification form and fax to 925-463-4600. Customers were asked to return unused products from the affected product codes and lots. The firm also recommended the replacement of affected tubes that were already in use as soon as clinically appropriate. The letter stated to return the affected product for credit or question contact Technical Services group at 800-635-5267 option 3, option 1 and reference the Return Goods Authorization number.
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
Screw, fixation, bone - Product Code HWC
Causa
One lot of the 010-55-030, 6.5 mm cancellous bone screw was recalled because a product complaint identified a mislabeling of the device. although the package label indicates size 30mm, the screw dimension is actually 25mm.
Acción
DJO Global sent an Urgent Field Safety Notice dated July 16, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the notice to all thoe who need to be aware within their organization or to any other organization where the potentially affected product was transferred, contact customers to place a replacement order and receive an RMA number, and return all affected devices using the RMA number. For questions customers should call 512-834-6255.
For questions regarding this recall call 512-832-9500.
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
Accelerator linear Medical - Product Code IYE
Causa
A software anomaly has been identified with the import export application version 11.0 where
mlc leaf positions for plans using brainlab m3 and mmlc are incorrectly imported.
Acción
Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only.
Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your system.
For further questions please call 1.888.827.4265.
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, blood, extra-luminal - Product Code FIR
Causa
On 07/09/2012, apheresis technologies, inc. initiated a recall on the plasma pump model pp-04a due to a complaint received regarding a rotor of the pp-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.
Acción
APHERESIS TECHNOLOGIES, INC. sent a letter dated July 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the device for repair. For questions customers should call 727-787-5616.
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 a potential to save reports in radreport with an incorrect final status.
Acción
McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.
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
Causa
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Acción
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the 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.
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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.
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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.
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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
Table, radiographic, tilting - Product Code IXR
Causa
Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
Acción
Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501
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
Causa
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Acción
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the 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.
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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.
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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
Intervertebral fusion device with bone graft, cervical - Product Code ODP
Causa
Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
Acción
Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832.
For questions regarding this recall call 352-377-1140.
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
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Causa
A fault in a high voltage relay in the 0-arm¿ imaging system might cause the relay to overheat and burn.
Acción
Medtronic Navigation issued an "Urgent Field Safety Notice" to consignees dated 7/11/12. The problem was described and recommended actions were provided. For each affected O-arm¿ Imaging System, a Medtronic service representative will visit the site and replace the 500VDC relay on the system and test the O-arm¿ Imaging System.
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.
Incorrect screw (rc) included with nc cares abutment set was not a narrow crossfit (nc) screw for cares nc abutment zro2.
Acción
Straumann notiifed accounts by telephone on July 10, 2012 and follow-up Field Safety Correction Action letter dated July 11, 2012, via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to discontinue use of the affected product and follow the instruction provided until replacement is received. For questions call 978-747-2514.
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.
Addendum labeling itotal cr surgical technique with detailed instructions of total cr poly insertion technique.
Acción
ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached.
For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, info@mdss.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.
Notas adicionales en la data
Drape, surgical - Product Code KKX
Causa
The impacted product was not intended for commercial distribution to end users.
Acción
Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer.
They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product according to their facility procedures. And to review their distribution records to identify all customers who were shipped any of the impacted products. Notify each of their customers who were shipped any of the impacted products by sending them a copy of the attached Customer Letter with the Customer Withdrawal Response Form. A minimum of three (3) attempts to contact each non-responding customer within interval of approximately four to six weeks will be performed.
Once all customers who were notified have responded or after approximately four weeks after the third attempt to contact the last non-responder, a recall Termination will be initiated
If your Kimberly-Clark Representative has not already contacted you, please contact the Ultra Fabric Reinforce surgical Gown Coordinator at (770) - 587-7700.
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.
Biomet 3i conducted a recall on the device low profile abutment, non-hexed castable cylinder due to some packages labeled lpccc1, hexed castable cylinder possibly containing lpccc2, non-hexed castable cylinders.
Acción
Biomet 3i sent a "MEDICAL DEVICE ADVISORY NOTICE" dated May 31, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this 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.
If multiple uncompressed images/clips are sent to the syngo dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
Acción
On 07/13/2012, Siemens issued a "Customer Safety Advisory Notice" to affected consignees according to Update Instruction SY062/121S. The notice informs the customers of the potential issue with the identified affected product and provides details regarding the resolution. A software update to relieve the symptom of the issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY063/121S. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instruction SY064/121S.
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
There is a variation of reticulocyte counts between xe series (xe-2100, xe-5000) and xt-series (xt-2000i, xt-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the xe-series because of a low bias.
Acción
Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate.
Any questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.
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.
The float valve in the burette sticks to the burette wall and does not open or close properly.
Acción
The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated July 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: hospira4921@stericycle.com; return affected product to Stericycle using the label provided with the letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.
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
Laparoscope, general & plastic surgery - Product Code GCJ
Causa
Some clip applier units may be inadequate to achieve clip closure.
Acción
TransEnterix sent an Urgent Device Recall letter date July 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product, remove the affected product from their inventory and either return it or dispose of it to prevent usage. Customers were instructed to complete the attached Inventory Reconciliation Formand return the form even if they no longer have any affected units in their inventory. Customers were instructed to ship the affected product to TransEnterix using the enclosed shipping label. If returning a form only, they should e-mail to adunn@transenterix.com. For questions customers were instructed to call 1-888-879-4111.
For questions regarding this recall call 919-765-8420.
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
Analyzer, chemistry, micro, for clinical use - Product Code JJF
Causa
Certain lots of cobas ampliprep (cap) s-tube input (box of 12 bags 12x24 s-tube and 12x24 s-clip) can cause the sample input tubes to stick in the barcode clips. as a consequence, the cap instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. no erroneous results would be produced if the issue occurs, but samples in proce.
Acción
On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions.
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
Retractor, self-retaining, for neurosurgery - Product Code GZT
Causa
Brainpath sheaths were mislabeled. sheaths which measure 50mm were labeled
as 60mm. the length callout on the label does not match the actual length of the sheath within the
packaging resulting in an improper fit as further explained below. this mislabeling was
discovered on 29-june-2012 during a clinical case.
Acción
NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form.
Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical.
For questions customers should call 888-632-7071.