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Cincinnati Sub-Zero Products Inc: Micro-temp II heat therapy unit, model #747.

There is the potential that the power switch assembly can dislodge from the cabinet during use.

FDAJan 18, 2005Nationwide• Cincinnati Sub-Zero Products Inc

Biolase Technology Inc: Waterlase MD, dental laser unit, Model #6200218, serial n...

Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

FDAJan 17, 2005Nationwide• Biolase Technology Inc

Medtronic Emergency Response Systems, Inc.: LIFEPAK 12 defibrillator/ monitors biphasic

The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

FDAJan 15, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Teleflex Medical: Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; a...

Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.

FDAJan 14, 2005Nationwide• Teleflex Medical

Interpore Cross International Inc: Spinal Implant, Catalog number: 1000-3000 through 1000-...

Mislabeled.

FDAJan 14, 2005CA, CO, IN +8 more• Interpore Cross International Inc

Millar Instruments, Inc: Mikro-Tip Disposable Angiographic Catheter manufactured b...

Wire braiding protruding from the catheter.

FDAJan 14, 2005CA, IN, MN +1 more• Millar Instruments, Inc

HP L2035 Flat Panel Monitor (Philips) – Technical Defect (2005)

The recall involves only the HP L2035 Flat Panel Monitor with serial numbers ranging from CNP352Y001 to CNP423Y1HS. The model number is displayed at the bottom, center of the monitor's bezel, just above the control buttons. The recalled monitors were produced from December 2003 through June 2, 2004.

CPSCJan 14, 2005Nationwide• Philips PC Peripherals, of Colorado Springs, Colo.

Bicycle Seats (Selle Royal/fi'zi:k) – Manufacturing Issue (2005)

The recall involves Selle Royal/fi'zi:k [cp] pavé bicycle seat part number 7403SXS 03 9072 with a manufacture date of 10/03. The bicycle seat is an original equipment (OEM) seat installed on 2004 model year Recreational Equipment Inc. (REI) brand Novara Express bicycles. The bicycle seat has a clear plastic base with "fi'zi:k", "made in Italy" and a date code dial printed on the base.

CPSCJan 14, 2005Nationwide• Selle Royal/fi'zi:k, of Pozzoleone, Italy

DS Golf Cars (Club Car) – Vehicle Performance (2005)

The recalled vehicles are used for short distance transportation around golf courses, hotels, resorts, airports, and residential communities. Vehicles subject to this recall can be identified by the serial number located above and to the right of the accelerator pedal. The names and serial numbers of the primary affected models are listed below Golf Cars DS Electric Golf Car- IQ System/ PowerDrive System 48 DS Gas Golf Car Café Express, Café Express Deluxe AA/AQ 0435-428922 to 0510-486815 AG 0435-426638 to 0509-484723 AF/WH 0436-429783 to 0509-485180 Utility Vehicles Carryall 1, Carryall Turf 1 Carryall 2, Carryall Turf 2 Carryall 2 Plus Carryall 272 F/FG/H/HG 0438-436726 to 0512-487151 E/EG/PG/RG/S 0435-429023 to 0512-487156 QG 0438-437967 to 0509-483847 Carryall 6, Carryall Turf 6 Carryall Turf 272 Carryall 472 J/JG/N/NG/TG 0433-417743 to 0510-486913 SG 0439-441898 to 0509-483925 QH 0439-441905 to 0510-485938 Transportation Vehicles Villager 4 Villager 6 Villager 8 FQ/TG 0435-426651 to 0510-486871 K/KG 0434-422986 to 0510-486892 M/MG 0433-417736 to 0510-486906 TransPorter 4 TransPorter 6 N/NG 0433-417743 to 0504-476683 J/JG 0434-422987 to 0510-486913 Rough Terrain Vehicles XRT 900 XRT 1200 XRT 1200 SE AE 0437-432848 to 0510-486889 AD 0439-442985 to 0510-486203 AH 0437-432899 to 0510-486199 Lynx Hunting Vehicle LX 0438-436718 to 0509-484151 Low Volume Models/Chassis Street Rod Electric Chassis BB 0438-436647 to 0438-436666 Bobcat 2100 Gas BK 0438-436988 to 0510-486876 Bobcat 2100S Gas BL 0438-436865 to 0510-486914 Indio Chassis 48V IQ CQ 0438-436667 to 0505-478022 Custom Solutions Standard Chassis CS 0440-444915 (one vehicle) Limo Electric (REGEN) LB 0438-436760 to 0509-484245 Limo Gas LG 0451-468002 to 0452-468972 Carryall Turf 2 XRT Gas XG 0437-436006 to 0510-486886 Carryall 2 XRT Gas ZG 0438-436770 to 0510-486905

CPSCJan 13, 2005Nationwide• Club Car Inc., of Augusta, Ga.

40-Watt Mini Spotlight Bulbs (Comtrad) – Fire Risk (2005)

Laceration Risk

The recalled 40-Watt "Type R" incandescent mini spot-light bulbs were included in two- and three-lamp accent lights in certain furniture hutch items manufactured by Sauder Woodworking Co. The furniture hutch models involved are: Model 9386 - Uses the three-lamp kit Model 9549 - Uses the two-lamp kit Model 9509 - Uses the two-lamp kit

CPSCJan 13, 2005Nationwide• Comtrad, Division of Waljon Ltd., Mississauga, Ontario, Canada

Ridgid 16-Gallon Blower Vac (Emerson Tool) – Operational Risk (2005)

Laceration Risk

The Ridgid® 16-gallon 2-in-1 Blower Vac, Model WD16650, has light gray drums with orange lids, gray power heads, and black wheels. The recalled units have the model number and a serial number from 04104C through 04114C located on a label on the side of the power head. "Ridgid® 2 in 1 Blower Vac" is written on the front of the units.

CPSCJan 13, 2005Nationwide• Emerson Tool Co., of St. Louis, Mo.

Mammut Barryvox Avalanche Transceivers – Technical Malfunction (2005)

The recalled Barryvoxes are 2004/2005 model Opto 3000 Avalanche Transceivers. The words, "Mammut" and "Barryvox" are printed on the front of the red and black transceivers. The serial numbers on the recalled units, which can be found in the battery compartment under the UPC code, include: M0080000 through M0088419, M0089616 through M0089800 and M0090000 through M0090419. The recalled units were shipped with an instructional CD and the box marked "Bonus CD Included." Units containing safe replacement transceivers have a red triangular label reading "New Casing" on the box.

CPSCJan 13, 2005Nationwide• Ascom Systec AG, Eichtal, of Switzerland

GE Oval and Double Dish Slow Cookers – Safety Defect (2005)

The recalled slow cookers include the 4.5-Quart Oval and 6-Quart Double Dish models sold under the General Electric (GE) brand name. The model name is printed on the front of the units. The 4.5-quart unit has model number 106661 and the 6-quart unit has model number 106851. Both models have series codes A through D, which are printed on the bottom along with the model number. The base of the slow cookers is white with an olive or honeysuckle graphic.

CPSCJan 13, 2005Nationwide

Flow MK Series Snowboard Bindings – Safety Issue (2005)

This recall includes 2004 Flow MK series snowboard bindings with model numbers MK03, MK04, MK05 and MK110. The bindings affected by this recall can be identified by the shape of the rear lock lever and the cable adjustment wheel on the side of the baseplate (as shown in the photos). No other bindings are included in this recall.

CPSCJan 13, 2005Nationwide

Residential Dining Chair (Poundex) – Structural Weakness (2005)

The recalled dining chair has a dark bronze metallic frame, birch colored wooden back and gold colored upholstered seat. The front and rear legs have a curved shape. The label under the seat reads, in part, "Imported by Poundex Associates Corp." The recalled dining chair is approximately 42 inches high and 17 inches wide.

CPSCJan 13, 2005Nationwide• Poundex Associates Corp., of City of Industry, Calif.

Fischer Imaging Corporation: Bloom DTU-215-B Programmable Stimulator

Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

FDAJan 13, 2005Nationwide• Fischer Imaging Corporation

Radiometer America Inc: D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, c...

QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.

FDAJan 12, 2005Nationwide• Radiometer America Inc

Cryolife Inc: CryoValve, Pulmonary Valve and Conduit

During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.

FDAJan 12, 2005KS• Cryolife Inc

Cordis Corporation: Polymeric coated stent. Cypher BX Velocity Cardio Siroli...

Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.

FDAJan 12, 2005Nationwide• Cordis Corporation

ProPack Backpack Sprayers (SHURflo) – Performance Problem (2005)

The recalled SHURflo ProPack Model SRS-540 rechargeable electric backpack sprayers have manufacture dates before September 2004. The model number and manufacture date are printed on a label affixed to the motor bracket, which can found by removing the battery pack. The sprayers have a clear or black hose, aluminum spray lance, and a white body. The words "SHURflo" and "Pro Pack" are printed on a label on the front of the unit.

CPSCJan 11, 2005Nationwide• SHURflo LLC, of Cypress, Calif.

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