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Showing 19721–19740 of 22584 results

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Medtronic Sofamor Danek USA Inc: 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spin...

Device distribution without marketing clearance

FDAJan 14, 2006LA• Medtronic Sofamor Danek USA Inc

American Medical Systems: her option Cryoablation Therapy Disposable Probe, Model C...

Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.

FDAJan 13, 2006Nationwide• American Medical Systems

Unknown Manufacturer: Porous titanium flared rim acetabular shell with three cl...

Voids in the porous coating of a component used in total hip replacement surgery.

FDAJan 12, 2006Nationwide

Thera Test Laboratories, Inc.: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic...

The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

FDAJan 11, 2006CA, CT, FL +4 more• Thera Test Laboratories, Inc.

Baxter Healthcare Corp. Rt.: Baxter Continuous Epidural Anesthesia Trays that contain ...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Epidural Anesthesia Trays that contain BD Catheter...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Combined Epidural Anesthesia Trays that contain BD...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Hospira Inc.: Hospira Transpac IV Monitoring Kit, 60 inch disposable tr...

The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

FDAJan 9, 2006OR• Hospira Inc.

Hospira Inc.: LifeShield Latex-Free Primary I.V. Set, Convertible Pin, ...

The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

FDAJan 9, 2006OR• Hospira Inc.

Hospira Inc.: Hospira Latex Free Blood Secondary Set, 26 inch with Secu...

The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

FDAJan 9, 2006OR• Hospira Inc.

Liko, Inc.: Liko Universal Slingbar 450 (aluminum) used with the Vik...

The swivel adapter which is mounted directly above the slingbar's split center bolt could be removed and allow the slingbar to be improperly mounted directly into the aluminum link arm. This could cause an unsafe transfer. Patient may fall.

FDAJan 9, 2006IL, MA, MO +2 more• Liko, Inc.

Joerns Healthcare Inc.: Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-H...

A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.

FDAJan 6, 2006Nationwide• Joerns Healthcare Inc.

Becton Dickinson & Company: Paradigm Link -- Blood Glucose Monitor.

BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

FDAJan 5, 2006Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: BD Logic -- Blood Glucose Monitor.

BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

FDAJan 5, 2006Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: BD Latitude (DMS) -- Blood Glucose Monitor.

BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

FDAJan 5, 2006Nationwide• Becton Dickinson & Company

Cook Endoscopy: SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR...

The dilator size does not match the label on the product and product packaging.

FDAJan 5, 2006Nationwide• Cook Endoscopy

Ethicon, Inc. US: PROCEED Surgical Mesh is a sterile, thin, flexible lamina...

Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.

FDAJan 4, 2006Nationwide• Ethicon, Inc. US

Diagnostic Products Corp.: IMMULITE 2000 Total Testosterone Kit

The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.

FDAJan 3, 2006Nationwide• Diagnostic Products Corp.

Wright Medical Technology Inc: Guardian Distal Femur Axial Pin

The product was not fully assembled prior to packaging.

FDAJan 3, 2006Nationwide• Wright Medical Technology Inc

Northwest Medical Physics Equipment Inc: Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-4...

Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.

FDAJan 2, 2006Nationwide• Northwest Medical Physics Equipment Inc

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