2010 Product Recalls
1,800 recalls issued in 2010.
Showing 1741–1760 of 1,800 recalls
Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.
Baxter sent the 11/27/06 Urgent Device Correction letter to all Flo-Gard Volumetric Infusion Pump customers, to the attention of the Vice President of Nursing and the Biomedical Engineer, via first class mail to alert them to the potential for non-detection of, and no alarm for, upstream occlusion under specific conditions for Flo-Gard Volumetric Infusion Pumps if the occlusion occurs above a flexible chamber (such as a drip chamber, Buretrol or blood filter), and to provide the addendum to the operator manual to address these specific conditions. The letters included the mitigations and risks associated with each of the conditions that could potentially cause this situation. This information was included in the letter, as well as the Operator''s Manual Addendum, which Baxter requested to attach a copy to all Flo-Gard Operator''s Manuals in their facility. Baxter instructed the customers to share this information with all staff members, services and facilities that use Flo-Gard pumps. Any questions were directed to Baxter''s Global Technical Services at 1-800-843-7867, prompt 2. Although Baxter previously notified customers on 3/5/99 that they would no longer support or service the Flo-Gard 6200 and 6300 devices as of 12/1/99, these product codes were included in this letter due to a similar potential for this issue. Should the customer still have these 6200 or 6300 devices in their possession, Baxter recommended that they be taken out of service due to obsolescence of the appropriate components. The accounts were requested complete the enclosed reply form acknowledging receipt of the letter and dissemination of the information to their staff.
Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option); Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
Important Product Information letters dated 2/8/06 were sent to the AS40 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the delay in the detection of a downstream occlusion when the AS40 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize infusion sets with thick-walled, small bore tubing to minimize the detection time; and * Always verify that the clamping device or stopcock is open in the fluid path prior to starting an infusion.
Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40; DM-MR0545 Monoaxi
This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA's concerns regarding Current Good Manufacturing Practice requirements of the Quality System without any product in the market so it could focus all of its efforts on responding to the FDA.
Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530
This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.
Allez Spine informed all parties who were in possession of the affected pedicle screws at the time of the initiation of this field action by phone on 11/08/2007 and requested the return of their inventory. All customers and consignees were contacted by the firm.
Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.
Incorrect expiration date on the product
The recalling firm issued Important Medical Device Product Recall Notice letters dated 5/7/09 via regular mail to their direct accounts explaining the reason for recall and requesting they discard all remaining units of the affected lot number in their inventory. A Product Inventory Checklist was enclosed to be returned in the enclosed self-addressed, stamped envelope to report the amount of product that was discarded. The Technical Services Department should be contacted at 800-447-3641 if there are any inquiries concerning the letter.
ELECTRICAL SHORT
AN ELECTRICAL SHORT MAY CAUSE A FIRE WITHOUT WARNING WHICH CAN RESULT IN PROPERTY DAMAGE, PERSONAL INJURY, OR DEATH.
NAVISTAR WILL NOTIFY OWNERS AND DEALERS WILL INSPECT THE BATTERY AND ECM CLEAN POWER CABLES, REPAIR IF NECESSARY AND REROUTE AWAY FROM THE PARKING BRAKE CABLE. REPAIRS WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR ABOUT MARCH 31, 2010. OWNERS MAY CONTACT NAVISTAR AT 1-260-461-1890.
LOSS OF STEERING CONTROL
AN INSUFFICIENT WELD COULD LEAD TO A SEPARATION OR PARTIAL SEPARATION OF THE PLATE AND CAUSE THE DRIVER TO LOOSE PROPER STEERING CONTROL OF THE VEHICLE, POSSIBLY RESULTING IN A CRASH.
NABI WILL NOTIFY OWNERS AND REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 26, 2010. OWNERS MAY CONTACT NABI CUSTOMER SERVICE AT 1-256-831-4296 EXT. 1308.
Silver Glitter Tea Lights; Gold Glitter Tea Lights Recalled for Fire Hazard
The flame from the tea lights can ignite the glitter on the candle, posing a fire hazard.
Consumers should immediately stop using the tea lights and return them to their nearest Pier 1 Imports retail store for a full refund or merchandise credit.
Ceramic Santa Tea Light Holders Recalled for Fire Hazard
The flame from tea lights can ignite these tea light holders, posing a fire hazard.
Consumers should stop using the Ceramic Santa Tea Light Holder immediately and return it to their nearest Pier 1 Imports retail store for a full refund or merchandise credit.
Diana Crib Recalled for Fall Hazard
The slats on the cribs drop-side can detach from the top and bottom rails, posing fall and entrapment hazards to the child.
Consumers should immediately stop using the recalled Diane crib and contact Caramia Furniture to receive a free replacement drop side. The free replacement will be available beginning March 2010.
ELECTRICAL SHORT
AN ELECTRICAL SHORT MAY CAUSE A FIRE WITHOUT WARNING WHICH CAN RESULT IN PROPERTY DAMAGE, PERSONAL INJURY, OR DEATH.
NAVISTAR WILL NOTIFY OWNERS AND DEALERS WILL INSPECT THE BATTERY AND ECM CLEAN POWER CABLES, REPAIR IF NECESSARY AND REROUTE AWAY FROM THE PARKING BRAKE CABLE. REPAIRS WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MAY 14, 2010. OWNERS MAY CONTACT NAVISTAR AT 1-260-461-1890.
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.
Marketed without a 510k or PMA submission to include the normative data display.
A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance. Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.
Mattress Sets Recalled for Fire Hazard
The mattress sets fail to meet the mandatory federal open flame standard and pose a fire hazard to consumers.
Consumers should immediately contact Mattress World to receive a full refund.
Rechargeable Batteries for Cordless Phones Recalled for Fire Hazard
The rechargeable batteries can overheat, posing a fire and burn hazard to consumers.
Consumers should immediately stop using the recalled batteries and contact Lenmar to receive a free replacement.
Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
The caster bolt stem/screw may loosen over time causing the wheel to come off.
Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.
Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic, Image-intensified.
possible injury to hand/fingers
Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.
Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
Table tilts: The Alphastar Surgical Table piston rod head may break and cause a full inclination of the table top during Trendelenberg positioning if there is insufficient lubrication.
Maquet sent Recall Notification letters to all customers on September 16, 2008 by Federal Express. Letters inform customers of the potential problem with the Alphastar tables, a description of the failure and hazards involved. Hospitals are asked to confirm whether yearly maintenance by an authorized technician have been performed. If preventive maintenance has not been performed, customers are requested to contact their Maquet Service rep. A Customer Service Response form is included and customers are to complete if to acknowledge whether of not the facility is still in possession of an affected table. If so, the model number, serial number and facility name & address is to be completed so that Maquet reps can visit the facility and perform the corrective action.
Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
CryoValve, Aortic Valve & Conduit
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
LED light kits Recalled for Fire Hazard
Defective wiring in the light kits can cause the battery pack to overheat and explode, posing a risk of burn and fire hazards to consumers.
Consumers should immediately stop using the recalled LED light kits and call Rockler Companies to receive a free repair kit and installation instructions.