2007 Product Recalls

1,625 recalls issued in 2007.

1,625
Total Recalls
452
CPSC
460
FDA Device
713
NHTSA
CPSC 452 FDA Device 460 NHTSA 713

Showing 61–80 of 1,625 recalls

CPSC

Specialized Bicycle Helmets Recalled for Fall Hazard

The helmets fail testing required under CPSC's safety standard for bicycle helmets. This can pose a head injury hazard to riders in a fall.

Consumers should stop using the recalled helmet immediately and return it to an Authorized Specialized Retailer to receive a free replacement or a full refund.

FDA

Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

Method is susceptible to positive interference from endogenous ALT in patient samples.

The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.

NHTSA

FUEL VENT PIPE WELD/FUEL TANK CRACKS

FUEL LEAKAGE IN THE PRESENCE OF AN IGNITION SOURCE CAN RESULT IN A FIRE.

DEALERS WILL INSPECT AND REPLACE THE FUEL TANK FREE OF CHARGE. THE RECALL BEGAN ON DECEMBER 7, 2007. OWNERS MAY CONTACT HONDA AT 866-784-1870.

NHTSA

ELASTIC STRAP FASTENER

THE ELASTIC STRAPS THAT SECURE THE PAD TO THE SHELL CAN COME LOOSE AND BE ACCESSIBLE TO THE CHILD. THE CHILD COULD THEN LOOP THE ELASTIC STRAP AROUND PORTIONS OF HIS OR HER BODY POSSIBLY RESULTING IN INJURY.

DOREL WILL NOTIFY REGISTERED OWNERS AND PROVIDE A FREE REPAIR KIT. THE RECALL BEGAN ON DECEMBER 18, 2007. OWNERS CAN CONTACT DOREL AT 1-888-698-6681, MONDAY THROUGH FRIDAY 8AM TO 4:30PM EST OR VISIT THEIR WEBSITE AT WWW.DJGUSA.COM.

NHTSA

FMVSS 404/BRAUN WHEELCHAIR LIFTS

SHOULD THE THRESHOLD WARNING SYSTEM FAIL TO OPERATE, THE LIFT USER CAN FALL FROM THE VEHICLE AND BE SERIOUSLY INJURED.

WINNEBAGO IS WORKING WITH BRAUN CORPORATION TO HAVE THE DOORWAY LIFT FIXED FREE OF CHARGE (PLEASE SEE 06E094). OWNERS MAY CONTACT BRAUN CORPORATION AT 1-800-946-7513.

NHTSA

ABS AND ESC CONTROL MODULES

THE EXTRA CHECK BALLS CAN RESTRICT THE FLOW OF BRAKE FLUID THROUGH THE VALVE AND CAUSE REDUCTION OF BRAKE FORCE.

EACH VEHICLE MANUFACTURER WILL FILE A DEFECT REPORT AND REMEDY PLAN FOR THEIR VEHICLES WHICH INCLUDED THESE MODULES AS ORIGINAL EQUIPMENT. VEHICLES WILL BE REPAIRED AT NO COST TO THE OWNER. OWNERS CAN CONTACT EITHER THEIR VEHICLE MANUFACTURER OR CONTINENTAL AUTOMOTIVE AT 248-393-5300 FOR FURTHER INFORMATION.

FDA

STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

Recall notification letters were mailed to consignees on 7/30/07 by first class mail.

FDA

VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138

Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.

The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.

FDA

Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio

Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.

The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.

FDA

Ultrasound probe cover, sterile. Catalog No. 910811.

Customer observed unsealed packages.

The recalling firm called their customer and requested the customer to return un-sealed packages.

FDA

Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.

Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.

FDA

Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.

Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.

The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.

NHTSA

BATTERY BOX CABLE

THIS SHORT CIRCUIT COULD RESULT IN A FIRE.

GIRARDIN WILL NOTIFY OWNERS AND REPAIR THE BUSES BY ADDING PROTECTIVE TUBES FREE OF CHARGE. THE RECALL BEGAN ON JANUARY 7, 2008. OWNERS CAN CONTACT GIRARDIN AT 819-477-8222.

NHTSA

LIGHTING SYSTEM/CIRCUIT BREAKERS

IF A SHORT CIRCUIT OCCURS AND IS LEFT UNTREATED, COMPONENTS AND WIRING MAY BE SUBJECT TO OVERHEATING WHICH COULD POSSIBLY RESULT IN A VEHICLE FIRE.

DEALERS WILL REPLACE THE CIRCUIT BREAKERS WITH FUSES. THE RECALL BEGAN ON FEBRUARY 25, 2008. OWNERS MAY CONTACT VOLVO TRUCKS AT 1-800-528-6586.

NHTSA

HEATER/DEFROSTER DUCT ROUTING

IF THIS REINFORCEMENT IS CONTACTED WITH AN ELECTRICAL POWER CONNECTOR, SUCH AS THE POWER STUD ON THE FIREWALL, IT MAY CAUSE AN ELECTRICAL SHORT RESULTING IN A SPARK AND POTENTIAL FIRE.

OWNERS WILL BE PROVIDED WITH INSTRUCTIONS ON HOW TO INSPECT THEIR VEHICLE FOR THE PRESENCE OF THE DEFECTIVE HEATER/AC HOSE DUCT. IF AFTER INSPECTION, THE VEHICLE IS DETERMINED TO HAVE AN IMPROPER HEATER/AC HOSE, KALMAR WILL SEND A REPLACEMENT HEATER/AC HOSE. THE RECALL BEGAN ON FEBRUARY 11, 2008. OWNERS MAY CONTACT KALMAR AT 1-786-229-6327.

NHTSA

REAR SLACK ADJUSTER CRACKING

REDUCED VEHICLE BRAKING COULD LEAD TO A CRASH.

DEALERS WILL INSPECT THE SLACK ADJUSTERS, AND REPLACE THE ADJUSTER IF FOUND DEFECTIVE. THE RECALL BEGAN ON JULY 31, 2008. OWNERS MAY CONTACT FREIGHTLINER AT 1-800-547-0712.

NHTSA

POWER STEERING FILTER PLUGS

SUDDEN LOSS OF STEERING ASSIST WITHOUT WARNING INVOLVING A MOTOR HOME COULD BE A PROBLEM FOR CERTAIN DRIVERS INCREASING THE RISK OF A CRASH.

DEALERS WILL REPLACE THE AFFECTED FILTERS WITH A LARGER FILTER. THE RECALL BEGAN ON JULY 2, 2008. OWNERS MAY CONTACT FREIGHTLINER AT 1-800-547-0712.

NHTSA

400 AMP FUSE LOCATION

THE DETERIORATION OF THE FUSE CAN CAUSE A DISRUPTION OF POWER RESULTING IN LOSS OF SERVICE IN THE PATIENT COMPARTMENT.

RETROFIT KITS AND INSTALLATION INSTRUCTIONS WILL BE MAILED TO CUSTOMERS FREE OF CHARGE. THE RECALL BEGAN ON JANUARY 8, 2008. OWNERS MAY CONTACT WHEELED COACH AT 800-932-7077.

NHTSA

HITCH PIN BOX LABEL INCORRECT

THIS LABEL IS GIVING CONFLICTING GVWR INFORMATION. THE GVWR OF THE TRAILER IS 18,000 LBS AND THE HITCH LABEL IS READING 15,500.

OWNERS WERE MAILED A CORRECTED LABEL AS WELL AS INSTALLATION INSTRUCTIONS. THE CUSTOMER WILL HAVE THE OPTION FOR DEALERS TO INSTALL THIS LABEL IF THEY PREFER. THE RECALL BEGAN ON OCTOBER 1, 2007. OWNERS MAY CONTACT FOREST RIVER AT 574-389-4600.

NHTSA

FMVSS 404/BRAUN WHEELCHAIR LIFTS

SHOULD THE THRESHOLD WARNING SYSTEM FAIL TO OPERATE, THE LIFT USER CAN FALL FROM THE VEHICLE AND BE SERIOUSLY INJURED.

CHAMPION IS WORKING WITH BRAUN CORPORATION TO HAVE THE DOORWAY LIFT FIXED FREE OF CHARGE (PLEASE SEE 06E094). OWNERS MAY CONTACT CHAMPION AT 1-800-331-5761 OR BRAUN CORPORATION AT 1-800-946-7513.