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Showing 65541–65560 of 68218 results

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Merit Medical Systems, Inc: IntelliSystem II Thermal Dot Matrix printer 110 V adapter...

Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

FDANov 7, 2005AL, IN, MD +8 more• Merit Medical Systems, Inc

Thomas Medical Products Inc: Bard electrophysiology SSV H. Lee 9.5F split sheath with ...

mislabeled as 9.5F actually contains 10.5F

FDANov 7, 2005CA, CO, IL +12 more• Thomas Medical Products Inc

Unknown Manufacturer: Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-0...

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

FDANov 3, 2005AZ, CA, FL +8 more

Unknown Manufacturer: Size 6 right Foundation Total Knee System (Catalog #324-0...

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

FDANov 3, 2005AZ, CA, FL +8 more

AGFA Corp.: CR DX-S, DX-S, Computed radiography system (Digitizer)

Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

FDANov 3, 2005MS, OR, DC• AGFA Corp.

Ormco Corporation: Damon 3 Bracket Upper Right lateral .022 slot Part Numbe...

Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

FDANov 3, 2005Nationwide• Ormco Corporation

C.R. Bard, Inc., Urological Division: Bard UroForce Balloon Dilation Catheter with Glissando Co...

There is a potential for the lumen to collapse and prevent passage over a guidewire.

FDANov 3, 2005Nationwide• C.R. Bard, Inc., Urological Division

Ciba Vision Corporation: AQuify Drops, Long Lasting Comfort Drops * Relieves Dryne...

Lack of assurance of sterility at the time of manufacture.

FDANov 2, 2005Nationwide• Ciba Vision Corporation

Hospira Inc: Hospira LifeCare PCA3 Infusion System Software, versions ...

Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

FDANov 2, 2005Nationwide• Hospira Inc

Abbott Spine: TraXis Vue Spinal Implant System, Part #2601-090921

Implants were manufactured without radiographic markers.

FDANov 2, 2005Nationwide• Abbott Spine

Boston Scientific Corporation One Boston: Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon...

Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.

FDANov 1, 2005Nationwide• Boston Scientific Corporation One Boston

Radiometer America Inc: D826 Accessory kit for single tcpO2 Electrodes for use wi...

Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations

FDANov 1, 2005AL, AK, AZ +39 more• Radiometer America Inc

Synovis Surgical Inovation Div. of: Peri-Strips Dry with Veritas Collagen Matrix Circular Sta...

The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

FDANov 1, 2005Nationwide• Synovis Surgical Inovation Div. of

Orthohelix Surgical Designs Inc: MaxLock Screwdriver, part MXS-056. This is a surgical in...

Screwdriver pilot taper tip can break during surgery.

FDANov 1, 2005CO, FL, GA +5 more• Orthohelix Surgical Designs Inc

Wahl Clipper Corp: Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic...

The massager may develop a crack in the cord insulation where it exits out of the strain relief. A crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.

FDANov 1, 2005Nationwide• Wahl Clipper Corp

Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan: The product is a mobile 3-wheeled electric scooter, model...

The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.

FDANov 1, 2005CA, IN, OH +1 more• Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan

Lifescan Inc: LifeScan OneTouch Ultra Test strips, lot number 2528640

Product may be defective and may give low inaccurate glucose results.

FDANov 1, 2005CA, IL, IN +7 more• Lifescan Inc

Terumo Cardiovascular Systems Corp: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.

FDANov 1, 2005Nationwide• Terumo Cardiovascular Systems Corp

CooperSurgical, Inc.: Milex 60cc Handy-Vak Locking Syringe Ref: MX500

Potential for the plunger to separate from the piston

FDANov 1, 2005CA, CO, HI +6 more• CooperSurgical, Inc.

Animas Corporation: Isulin Pump. Model IR1000

Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.

FDAOct 31, 2005CA, CO, FL +13 more• Animas Corporation

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