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
Toothbrush, Powered - Product Code JEQ
Causa
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
Acción
The recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.
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
Toothbrush, Powered - Product Code JEQ
Causa
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
Acción
The recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.
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
Toothbrush, Powered - Product Code JEQ
Causa
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
Acción
The recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.
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
Toothbrush, Powered - Product Code JEQ
Causa
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
Acción
The recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.
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.
Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
Acción
On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the 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.
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
Acción
Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
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.
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
Acción
Urgent Device Correction letters dated 3/3/05 were sent to the direct accounts via first class mail, to the attention of the Director of Nursing. The accounts were informed of the field reports received concerning the PosiFlow Access Device and IV sets containing the PosiFlow device and the changes made to the directions for use and in-service training materials to correct the problems. The accounts were requested to complete and fax back to Baxter at 847-270-5457 the enclosed customer reply form, acknowledging the receipt and dissemination of the information to their staff. Wholesalers were requested to notify their customers. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
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
Product is marketed without a 510(k).
Acción
The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.
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
Endoscope, Neurological - Product Code GWG
Causa
Products are mislabeled.
Acción
Recall letters were sent to customers on 2/28/05 requesting return for 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
Endoscope, Neurological - Product Code GWG
Causa
Products are mislabeled.
Acción
Recall letters were sent to customers on 2/28/05 requesting return for 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
General Surgery Tray - Product Code LRO
Causa
There is a potential for open side seals post-sterilization of the tyvek breather pouches used in the custom sterile packs.
Acción
Field Correction letters dated 3/4/05 were sent to thedirect account hospitals on the same date to the attention of the manager of surgery, informing them of the potential indadequate side seal of the Tyvek breather pouches in the packs which may cause a compromise in the sterility of the product. The accounts were provided a list of the affected pack sent to the account and were requested to inspect any stocks of the affected product in stock, using the enclosed diagrams as an aid in the inspection for the defective side seals. Any defective product found should be returned to Medline. Any questions were directed to Lara Simmons, QA/RA Director at 1-800-879-2781, ext. 6072.
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, Syringe Needle - Product Code KZH
Causa
Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
Acción
Consignees were notified via recall letter dated March 8, 2005 and asked to retun any unused 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.
Shoulder positioner may break near the rail that attaches to the operating table.
Acción
Allen Medical notified consignees by letter dated 3/4/05 via Fed''X. Facilities are requested to remove the shoulder positioner and return it per the listed instructions .
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
Hepatitis A Test (Antibody And Igm Antibody) - Product Code LOL
Causa
Abbott identified through investigational studies that imxhavab controls lot 21059q100 is generating negative control values outside the upper range specified in the imxhavab package insert.
Acción
Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.
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
Clip, Implantable - Product Code FZP
Causa
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the absolok extra packaging.
Acción
The recalling firm sent a letter, dated 2/28/05 to 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
Scissors, General, Surgical - Product Code LRW
Causa
Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
Acción
The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.
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
Test, Time, Prothrombin - Product Code GJS
Causa
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Acción
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
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
Test, Time, Prothrombin - Product Code GJS
Causa
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Acción
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
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
Test, Time, Prothrombin - Product Code GJS
Causa
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Acción
Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
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
System, Blood Culturing - Product Code MDB
Causa
Blood culture bottles with an error in the bar code on the labels, were shipped.
Acción
The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for 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
System, Thermal Regulating - Product Code DWJ
Causa
Air channel seals on a limited number of bair hugger model 555 pediatric underbody blankets could separate when inflated with air from bair hugger warming unit. this separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
Acción
Recall notification was mailed to customers beginning 03/11/05. Customers were informed of the issue and asked to check their inventory for the affected lots. Affected lots found are to be quarantined and customers are to contact Arizant for instruction on returning affected product and receiving replacement product. Distributors are instructed to examine their inventory for affected lots, discontinue distribution and quarantine the lots. Distributors are asked to contact Arizant for returning affected product. If affected product was distributed, Distributors are to contact Arizant with names, addresses and telephone numbers of their accounts so Arizant can immediately inform those accounts of the 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.
Linvatec has determined that there is a possibility that the pouch tyvek header to foil longitudinal seal was not properly sealed by bemis flexible packaging, in all pouches, prior to sterilization by linvatec. therefore there is a potential for compromised sterility of the devices.
Acción
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
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.
Linvatec has determined there is a possibility the pouch tyvek header to foil longitudinal seal was not properly sealed by bemis flexible packaging, in all pouches, prior to sterilization by linvatec. therefore there is a potential for compromised sterility of the devices.
Acción
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
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.
Linvatec has determined there is a possibility the pouch tyvek header to foil longitudinal seal was not properly sealed by bemis flexible packaging, in all pouches, prior to sterilization by linvatec. therefore there is a potential for compromised sterility of the devices.
Acción
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.