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
Radiographic Collimator - Product Code IZX
Causa
The d800 swivel collimator may come loose from the tubestand and fall onto the x-ray table.
Acción
The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.
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
Stainless steel guidewire - Product Code MPB
Causa
Metal guidewires used in hemodialysis catheters may have been reverse loaded within the dispenser. potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.
Acción
Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.
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
bur - Product Code GFF
Causa
Compromised sterility: conmed linvatec medical devices packaged within a certain peel pouch sterile package may have compromised sterility due to an improper seal.
Acción
Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.
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
Microkeratome - Product Code HMY
Causa
Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.
Acción
BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.
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
Radiographic Collimator - Product Code IZX
Causa
The e600 swivel collimator may come loose from the tubestand and fall onto the x-ray table.
Acción
The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.
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
Radiographic Collimator - Product Code IZX
Causa
The f100 swivel collimator may come loose from the tubestand and fall onto the x-ray table.
Acción
The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.
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 Convenience Kits - Product Code LRO
Causa
Expiration dating; some convenience kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.
Acción
An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their 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 System - Product Code BSP
Causa
Guidewire breakages: during the functional anaesthetic discography (f.A.D.) procedure.
Acción
A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new 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
Microbiological media plates - Product Code JSO
Causa
Marketed a regulated product without a 510(k).
Acción
Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy 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
surgical blade - Product Code GES
Causa
Complaints received of rust on the blades of bd bard-parker surgical blades.
Acción
Urgent recall letters were sent out 8/10/2007 via UPS second day air.
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
blood glucose meter - Product Code NBW
Causa
Damage could lead to no display. meters manufactured after january 31, 2007 could exhibit meter display damage if dropped on a hard surface. these meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.
Acción
Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter.
Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be created and communications tracked according to local requirements. Abbott issued a Press Release August 31, 2007 also.
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 blade - Product Code GES
Causa
Complaints received of rust on the blades of bd bard-parker surgical blades.
Acción
Urgent recall letters were sent out 8/10/2007 via UPS second day air.
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
ANESTHESIA MEDICATION STATION - Product Code BRY
Causa
System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.
Acción
The field action consisted of phone calls and a mailing conducted to all customers for the Pyxis Anesthesia System 3500 beginning on 08/13/2007. The customers will be notified by registered return receipt mail by Recall Notifications dated August 14, 2007. Separate letters will be sent to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix and a long-term fix of the software will be issued shortly.
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
Microbiological media plates - Product Code JSO
Causa
Plates manufactured without vancomycin. possibility for false resistant results.
Acción
On 4/23/07 the firm began contacting customers via fax and telephone.
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
angiographic x-ray system - Product Code IZI
Causa
Unintended movement of the system table and/or c arm.
Acción
Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
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
Infusion Pumps - Product Code FRN
Causa
Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
Acción
The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.
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
Implantable Pulse Generator - Product Code LGW
Causa
Mislabeled: product labeled with the incorrect shelf-life information.
Acción
There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.
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
Power conditioner - Product Code JAK
Causa
The teal power conditioning units may fail and result in the unit emitting fire and/or smoke. note: the teal power conditioning unit has the potential to fail when the scanner that is attached to the teal is powered and in use as well as when not in use.
Acción
On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians.
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 prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled 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
software used with PET Scanner, for nuclear medicine imaging - Product Code KPS
Causa
Naviscan has identified a potential safety issue with all versions of pem view software commonly used for analyzing patient images acquired on the pemfiex product line.
1. the positron emission mammography standardized uptake value (pemsuv) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet rema.
Acción
Telephone notification regarding issues #1 and #2 were carried out on August 1 and 2, 2007 and included instructions for a validated work-around to avoid the software issues. Written notifications with these same validated work-around instructions were sent on August 2, 2007 via certified mail. Customers were notified that Naviscan has identified a potential safety issue with all versions of PEM View Software.
Issue #3 was identified after the notification to customers for issues #1 and #2. Telephone notification regarding issues #3 was carried out via telephone and certified mailing beginning August 16, 2007. Customers were informed that Naviscan is preparing software to resolve these issues and that they would be contacted by Naviscan Customer Support to ensure they thoroughly understand the issues and the recommended procedure to prevent these issues from occurring.
If customers have any questions they were instructed to contact Naviscan Customer Support at 1-888-628-4159 or service@navsicanpet.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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled 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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled 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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled 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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled 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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.