2010 Product Recalls
1,800 recalls issued in 2010.
Showing 41–60 of 1,800 recalls
Baby leg warmers and socks Recalled for Choking Hazard
The leg warmers and socks have a heart appliqué that can detach, posing a choking hazard to small children.
Consumers should immediately take the recalled socks and leg warmers away from children. Consumers can remove and discard the heart appliqué to eliminate the hazard or contact BabyLegs to receive a full refund or a coupon to be redeemed on the BabyLegs website.
Metallic spinning candle holders with 12 soy tea lights Recalled for Fire Hazard
The candle holders can catch fire, posing a fire hazard to consumers.
Consumers should immediately stop using the candle holder. QVC has notified consumers who purchased the candle holders through a QVC television program or QVC.com to stop using the product. During the week of December 20, 2010, all purchasers will be mailed instructions on how to receive a full refund. Consumers who have not received the information package by January 10, 2011 should contact QVC to receive the information.
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.
On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.
AIR BAG PASSENGER SENSING SYSTEM
NON-DEPLOYMENT OF THE FRONT PASSENGER AIR BAG IN THE EVENT OF A CRASH NECESSITATING THAT AIR BAG'S DEPLOYMENT MAY REDUCE PROTECTION OF THE PASSENGER AND INCREASE THE RISK OR SEVERITY OF INJURY TO THEM.
DEALERS WILL REPLACE THE PASSENGER SENSING SYSTEM FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN ON OR ABOUT MARCH 15, 2011. OWNERS MAY CONTACT CADILLAC AT 1-866-982-2339, CHEVROLET AT 1-800-630-2438, GMC AT 1-866-996-9463 AND AT THE OWNER CENTER AT WWW.GMOWNERCENTER.COM.
REAR AXLE CROSS PIN FRACTURE
THE DRIVER MAY NOT BE ABLE TO MAINTAIN DIRECTIONAL CONTROL OF THE VEHICLE AND A CRASH COULD OCCUR WITHOUT WARNING.
DEALERS WILL INSTALL A NEW REAR AXLE CROSS PIN FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 11, 2011. OWNERS MAY CONTACT CADILLAC AT 1-866-982-2339, CHEVROLET AT 1-800-630-2438, GMC AT 1-866-996-9463 AND AT THE OWNER CENTER AT WWW.GMOWNERCENTER.COM.
EMERGENCY EXIT WINDOW
THE EMERGENCY EXIT WINDOW MAY SEPARATE FROM THE BODY AND COULD FALL INCREASING THE RISK OF INJURIES TO THE PASSENGER OR DRIVER.
DEALERS WILL REPLACE THE EMERGENCY EXIT WINDOW IF NECESSARY FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 11, 2011. OWNERS MAY CONTACT SPRINTER AT 1-201-573-0600.
TRANS/AIR TA-73 EVAPORATOR/OVERHEATS
THIS WOULD CAUSE THE RESISTOR TEMPERATURE TO RISE TO A POINT WHERE IT WILL MELT AND POSSIBLY IGNITE THE PLASTIC BLOWER HOUSING TO WHICH IT IS MOUNTED. THE OVERHEATING CAN RESULT IN A FIRE.
ELKHART COACH IN COOPERATION WITH TRANS AIR WILL INSTALL A THERMAL SHUTDOWN DEVICE IN SERIES WITH THE SPEED RESISTORS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 15, 2010. OWNERS MAY CONTACT TRANS AIR WARRANTY AND SERVICE CENTER AT 1-800-673-2446.
FRONT SUSPENSION DAMPER BOLTS AND SPINDLE NUTS
LOSS OF STEERING INCREASES THE RISK OF A CRASH.
DEALER WILL INSPECT AND REPLACE ANY LOOSE FRONT DAMPER BRACKET BOLTS OR SPINDLE NUTS ON THE PILOT IF NECESSARY. DEALER WILL INSPECT AND REPLACE THE SPINDLE NUTS ON THE ACCORD V6 IF NECESSARY. THE SAFETY RECALL BEGAN DECEMBER 23, 2010. OWNERS MAY CONTACT HONDA AT 1-800-999-1009.
ENGINE OIL FILLER PLUG/DIPSTICK
IN ADEQUATE OIL LEVELS MAY CAUSE THE ENGINE MAY TO SEIZE LEADING TO A LOSS OF CONTROL OF THE VEHICLE AND INCREASING THE RISK OF A CRASH.
DEALERS WILL REPLACE THE ENGINE OIL PLUG/DIPSTICK FITTED TO THE CLUTCH COVER. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 24, 2010. OWNERS MAY CONTACT TRIUMPH MOTORCYCLE AT 678-539-8782.
INTAKE MANIFOLD SHIELD REMOVAL
FUEL LEAKAGE, IN THE PRESENCE OF AN IGNITION SOURCE, COULD RESULT IN A FIRE.
EXECUTIVE COACH WILL SUPPLY KITS AND INSTALLATION INSTRUCTIONS TO HAVE VEHICLES REPAIRED AT A FACILITY OF THE OWNER'S CHOICE. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 1, 2010. OWNERS MAY CONTACT EXECUTIVE COACH AT 888-322-9272.
Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073. Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.
The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.
Silver Tree Tealight Candle Holders Recalled for Fire Hazard
The tealight cups are positioned where the flame from the candles can ignite other parts of the candle holder, posing fire and burn hazards to consumers.
Consumers should immediately stop using the recalled candle holders and return the product to any Michaels Arts & Craft store for a full refund.
Zoom Buggy Car and Dream Pillow Star educational toys Recalled for Choking Hazard
The wheels on the Zoom Buggy cars and plastic beads on the Dream Pillow Star can detach, posing a choking hazard to young children.
Consumers should stop using and discard the recalled items immediately and contact their Kindermusik Educator for a replacement.
Classic Buggies Recalled for Injury Hazard
The off-road vehicles can accelerate without warning, posing a risk of injury to the user and/or bystanders.
Consumers should immediately stop using the buggies and contact their BB Buggies dealer to schedule a free repair.
Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; Product is manufactured and distributed by Siemens Medical Solutions, Oncology Care System, 4040 Nelson Ave, Concord CA The product is indicated for use in Radiation therapy simulation.
The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.
Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.
The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.
The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice. For questions or assistance, please contact Zimmer Spine at 800-326-0635.
TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.
A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.
Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.
Volcano issued a Voluntary Recall of Volcano s5 Family Software version 3.2 letter dated June 30, 2010, identifying the software defect and actions to be taken by Volcano. Field Service Engineers will visit each site and reinstall the previous software version, which will resolve the issue. Customers can contact Volcano at 916 281-2790.
LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II); The Lap-Band System is a long-term implantable device intended to induce weight lo
In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling
Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees. The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations. Customers were instructed to follow the Directions for Use for inserting the needle. Customers were instructed to report any malfunction or adverse event related to the device to Allergan Product Support at 1-800-624-4261 ext. 5972 or 1-805-961-5972 and FDA's Medwatch Program (1-800-FDA-1088 or www.fda.gov/medwatch). For questions, consignees were instructed to contact their Allergan field representative or contact Allergan Product Support at 1-800-624-4261.