2007 Product Recalls

STEERING GEAR SPACER/FREIGHTLINER/ZF

THE OPERATOR MAY NOTICE HIGHER REQUIRED STEERING WHEEL INPUTS, OR THE NEED FOR MORE STEERING WHEEL ADJUSTMENTS WHILE DRIVING IN A STRAIGHT LINE IN COMBINATION WITH METALLIC CRACKING NOISES PRIOR TO A LOSS OF STEERING. LOSS OF STEERING COULD RESULT IN A VEHICLE CRASH.

FLEETWOOD IS WORKING WITH FREIGHTLINER AND ZF TO REPLACE THE STEERING GEAR FREE OF CHARGE (PLEASE SEE 07V343 AND 07E049). OWNERS MAY CONTACT FLEETWOOD AT 1-800-322-8216 OR FREIGHTLINER AT 1-800-547-0712.

EXPOSED TERMINAL TO OIL DIPSTICK

WHEN THE OIL LEVEL IS CHECKED, IT MAY BE POSSIBLE FOR THE DIPSTICK TO CONTACT THE EXPOSED WIRE TERMINAL STUD AND IF OTHER END OF THE DIPSTICK IS GROUNDED, THIS COULD RESULT IN AN ELECTRICAL SHOCK OR A SPARK WHICH COULD CREATE A FIRE.

DEALERS WILL REMOVE THE WIRE FROM THE TERMINAL AND INSTALL BOOT COVERS, THEN REINSTALL THE WIRE AND SLIP COVER OVER THE CONNECTION. THE RECALL BEGAN ON MARCH 3, 2008. OWNERS MAY CONTACT MONACO AT 1-800-685-6545.

REPLACEMENT WHEEL HUB ASSEMBLIES

WHEEL SEPARATION CAN RESULT IN A VEHICLE CRASH.

FEDERAL-MOGUL WILL NOTIFY CUSTOMERS AND WILL REPLACE THE HUB ASSEMBLY FREE OF CHARGE. THE RECALL BEGAN ON FEBRUARY 7, 2008. OWNERS CAN CONTACT FEDERAL-MOGUL TOLL-FREE AT 877-489-6659.

CRUISE CONTROL SWITCH

THIS COULD POSSIBLY RESULT IN THE CRUISE CONTROL NOT DEACTIVATING WHEN THE BRAKE PEDAL IS PRESSED, WHICH MAY RESULT IN A VEHICLE CRASH.

DEALERS WILL INSPECT THE SWITCH AND REPLACE IT IF NECESSARY. THE RECALL BEGAN ON JANUARY 2, 2008. OWNERS MAY CONTACT MACK ON 1-800-528-6586.

Holiday Cosmetics Stuffer Bears Recalled for Choking Hazard

The neck medallion zipper pull can detach, posing a choking hazard to young children.

Consumers should immediately stop using the stuffer bears and keep out of the reach of young children. Victoria's Secret has sent consumers a postage paid return mailer enclosed. Customers returning the bear will receive a refund, postage and a $10 gift certificate.

Soldier Bear Toys Recalled for Poisoning Hazard

The surface paint on the toys contains excessive levels of lead, violating the federal lead paint standard.

Consumers should immediately take the recalled toys away from children and return them to the nearest AAFES store for a full refund.

Ski-Doo® Model Year 2008 MXZ X 600 RS Snowmobiles Recalled for Poisoning Hazard

A defect in the carburetor can prevent the throttle from freely returning to the idle position. This can result in an unexpected loss of control, leading to a collision, and cause serious injuries or death.

Consumers should stop using these vehicles immediately and contact any Ski-Doo dealer to schedule a free repair. Consumers with recalled snowmobiles are being sent direct notices from Bombardier.

Giant Measuring Chart Recalled for Poisoning Hazard

The paint on the grow chart contains excess levels of lead, violating the federal lead paint standard.

Consumers should stop using the chart immediately and contact Discount School Supply to receive a credit or refund.

Jostra HL-20 Heart Lung Machine - guiding pins

The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.

An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.

Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank

The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.

The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.

Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delive

Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.

Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.

Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Ann

Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.

Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX

Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.

Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.

Components may not lock together as intended.

Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.

Honda Walk-Behind Lawn Mowers Recalled for Laceration Hazard

The cutting blades could rotate under power when the control lever is released. The lawn mowers do not comply with mandatory federal safety standards for lawn mowers. The spinning blade poses a serious laceration hazard to consumers.

Consumers should stop using these recalled lawn mowers immediately and contact any Honda Lawn and Garden dealer for a free repair. Registered owners will be mailed a direct notice.

REAR FENDER STRUT BOLT

THIS COULD OCCUR WITHOUT PRIOR WARNING AND COULD RESULT IN AN INJURY OR A CRASH.

DEALERS WILL REMOVE EXISTING STRUT BOLTS AND REPLACE WITH HIGHER TENSILE STRENGTH ATTACHING BOLTS AND UPDATED WASHERS. HIGHER TORQUE VALUES WILL BE OBSERVED WHEN INSTALLING THE REPLACEMENT FASTENERS. THE RECALL BEGAN ON JANUARY 21, 2008. OWNERS MAY CONTACT BIG DOG AT 316-267-9121.

PROPELLER SHAFT

IN THIS CONDITION, THERE IS A POSSIBILITY THAT THE YOKE MAY BREAK CAUSING THE PROPELLER SHAFT TO SEPARATE AT THE JOINT AND COME INTO CONTACT WITH THE ROAD SURFACE OR THE FUEL TANK WHICH COULD RESULT IN A LOSS OF VEHICLE CONTROL OR A FUEL LEAK.

DEALERS WILL INSPECT THE SLIP YOKE AND REPLACE THE PROPELLER SHAFT IF NECESSARY FREE OF CHARGE. THE RECALL BEGAN ON JANUARY 7, 2008. OWNERS MAY CONTACT TOYOTA AT 1-800-331-4331.

FRAME TO MAIN CHASSIS CRACKS

THE CHASSIS AND BOX CAN SEPARATE FROM THE DRAWBAR CAUSING A LOSS OF CONTROL WHICH COULD RESULT IN A CRASH.

TRAILER OWNERS WILL INSPECT THE WELDS WHERE THE SLOPED FRAME 'NOSE' WELDS TO THE HORIZONTAL MAIN FRAME RAILS. IF CRACKS ARE FOUND, A FRAME UPDATE KIT WILL BE SENT TO THE OWNERS TO HAVE THE REPAIRS PERFORMED LOCALLY. THE RECALL BEGAN ON DECEMER 20, 2007. OWNERS MAY CONTAT TRUCK EQUIPMENT AT 1-402-476-3225.