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.
Notas adicionales en la data
Pump, infusion - Product Code frn
Causa
Potential delay/underinfusion of critical therapy-- devices experience increased frequency of alarms that result in temporary pump stoppage.
Acción
Hospira, Inc. issued an "Urgent: Device Field Correction" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades.
For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100.
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
Breathing circuit - Product Code CAI
Causa
Breathing circuit inner tube may separate from the rigid connectors under certain conditions.
a separation of the inner tube from the connector may prevent adequate gas flow (o2, n2o and anesthetic agents) to the patient. a separation can also cause co2 re-breathing. this could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.
Acción
GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.
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
Intraoral Dental Drill - Product Code DZA
Causa
Some of the packages of act3020, drills may actually contain an act3220 drill.
Acción
Consignees were notified of recall by telephone and by faxed an Urgent: Medical Device Recall letter, dated June 30, 2009. The letter stated the problem. The letter also asked customers to check their surgical kits and confirm the drill is placed in the correct space within the kit. Customers are to verify that the shank of the drill is marked as ACT3020 on one side and as 3.0 x 20mm on the opposite side. The letter also stated the clinical implications. Customers are to respond with the attached response fax and then return the drills to BIOMET 3i. Once the returned product is received, replacement drills will be sent to the customers. Questions or concerns should be directed to Kelly Taylor at 561-776-6906.
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
B. braun interventional systems was notified by b. braun medical france, the manufacturer of the celsite access port that they had received 11 reports of polyurethane (type p) catheter disconnections.
b. braun medical france has decided to recall all celsite¿ ports supplied with the affected catheter lot. to date, b. braun interventional systems (us) has not received any reports of catheter dis.
Acción
B. Braun Interventional Systems, Inc. issued an "Urgent: Medical Device Recall" notice dated June 22, 2009. The letter identified the problem and product. The letter reminded the consignee of the general instruction for use of access ports and instructed them to contact patients who had the Celsite port system implanted.
For further questions, contact B. Braun Interventional Systems, Inc. at 1-800-523-9676 extension 4818.
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
Implant, endosseous, root-form - Product Code KKO
Causa
Size printed on product packaging does not match size of enclosed product.
Acción
A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.
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
Hip joint metal/polymer semi-constrained cemented prosthesis - Product Code JDI
Causa
Radius at the end of the taper of the femoral implant is smaller than specification. this error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. the deficiency may not be noticed by the user. impingement and/or wear debris may lead to revision.
Acción
All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. Further questions are directed to the contacts at Smith and Nephew listed in the letter.
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
Hip joint metal/polymer semi-constrained cemented prosthesis - Product Code LZY
Causa
46 mm femoral head was mismarked and packaged as being 45 mm.
Acción
All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health.
Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any 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
external fixation of finger joint - Product Code JDW
Causa
Hinge failure: the product is cracking or breaking during use.
Acción
The Smith & Nephew Sales Representatives were notified of the problem and the recall via certified letter and e-mail on 01/23/2009. A second notice was sent to the hospitals on 06/06/2009. All affected Smith & Nephew International Distributors were notified via email on 01/23/2009. They were instructed to immediately notify their accounts concerning the recall. Smith & Nephew c/o Return Goods, 4287 Delp St, Memphis, TN 38118
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
Edwards lifesciences llc received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
Acción
Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned.
For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.
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.
Healing abutment was not made within required manufacturing specification. the product did not have the relief behind the thread, which does not allow proper seating.
Acción
Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any 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
Biological Sterilization Process Indicator - Product Code FRC
Causa
Biological indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.
Acción
An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.
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
Three occurrences of twin-pass¿ catheters containing a piece of ptfe beading material in the otw lumen have been reported to vascular solutions. the ptfe beading material is a processing aide used during hydrophilic coating. the beading is to be removed followed by a visual inspection prior to packaging.
Acción
Vascular Solutions, Inc. issued an "Urgent: Medical Device Recall - Lot Specific" notice dated July 6, 2009. The letter described the problem and product involved and asked Consignees to immediately check their Twin-Pass¿ catheter inventory, remove any affected units and complete the Product Recall Inventory Form and return to Customer Service Department.
For further questions, contact Vascular Solutions, Inc. at 1-763-656-4300.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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.
The tulip portion of the screw assembly can disengage from the shank after implantation.
Acción
Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
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
Diagnostic Biliary Catheter - Product Code FGE
Causa
Ev3 inc. is conducting a voluntary recall of specific lots of the protege gps self-expanding stent system because labeling did not match the actual stent size contained in the package. the affected product was labeled as a 6mm x 80mm protege gps stent but actually contained an 8mm x 40mm stent. this situation can lead to vessel damage or inadequate coverage of the target lesion.
Acción
Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".