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Showing 18381–18400 of 22584 results

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Sunnex Inc.: Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in...

Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

FDAFeb 13, 2007Nationwide• Sunnex Inc.

3M Espe Dental Products: 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/...

Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.

FDAFeb 12, 2007AZ, CA, IN +3 more• 3M Espe Dental Products

Stryker Howmedica Osteonics Corp.: Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbe...

Laceration Risk

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

FDAFeb 12, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Bio-Rad Laboratories Inc: Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog ...

The product may produce a faint line which could be interpreted as a false negative test result .

FDAFeb 12, 2007Nationwide• Bio-Rad Laboratories Inc

Stryker Howmedica Osteonics Corp.: Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numb...

Laceration Risk

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

FDAFeb 12, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Bausch & Lomb Inc: Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. ...

Laceration Risk

The cutter probe tip breaks during use.

FDAFeb 9, 2007CA, FL, MO +2 more• Bausch & Lomb Inc

Ekos Corp: EKOS EndoWave Infusion System and EKOS Lysus Infusion Sys...

Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.

FDAFeb 9, 2007Nationwide• Ekos Corp

HoMedics, Inc.: HoMedics Thera P Model King size Moist/Dry Heating Pad wi...

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

FDAFeb 9, 2007Nationwide• HoMedics, Inc.

Curlin Medical Llc: Curlin Medical Administration Sets: Model Numbers 340-41...

The Administration Sets may leak at the reservior bag.

FDAFeb 9, 2007PA• Curlin Medical Llc

HoMedics, Inc.: HoMedics Thera P Standard size Dry Heating Pad; Model No....

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

FDAFeb 9, 2007Nationwide• HoMedics, Inc.

American Medical Systems: AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis wit...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

American Medical Systems: AMS 700 Ultrex Preconnected penile Prosthesis with Inhibi...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

GE OEC Medical Systems, Inc: OEC 9800 Fluoroscopic X-ray System, Model Number A349855,...

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC 9800 Plus Fluoroscopic X-ray System,

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

American Medical Systems: AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, pro...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

Digisonics, Inc: Doctors Review System, OB-Windows/OB-View software releas...

Study would on occasion have fetal heart rate and/or cervical length on the report that was not entered nor did it belong to that patient. Software displayed incorrect data for fetal heart rate and cervical length in OB ultrasound reports.

FDAFeb 9, 2007Nationwide• Digisonics, Inc

GE OEC Medical Systems, Inc: OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray Sys...

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

Bausch & Lomb Inc: Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior ...

Laceration Risk

The cutter probe tip breaks during use.

FDAFeb 9, 2007CA, FL, MO +2 more• Bausch & Lomb Inc

HoMedics, Inc.: HoMedics Thera P King size Moist/Dry Heating Pad; Model ...

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

FDAFeb 9, 2007Nationwide• HoMedics, Inc.

American Medical Systems: AMS 700 CX Preconnected penile Prosthesis with InhibiZone...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

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