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Showing 19941–19960 of 22584 results

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Baxter Healthcare Corp. Rt.: AP II Pain Management System infusion pump, product codes...

When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.

FDAOct 27, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter I-Pump Pain Management System infusion pump, produ...

When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.

FDAOct 27, 2005Nationwide• Baxter Healthcare Corp. Rt.

Sonosite, Inc.: SonoCalc IMT 3.0, a windows based software used in conjun...

When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result.

FDAOct 26, 2005Nationwide• Sonosite, Inc.

Diagnostica Stago, Inc.: STA Liatest Free Protein S, cat. 00516. These kits are i...

The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

FDAOct 26, 2005Nationwide• Diagnostica Stago, Inc.

Becton Dickinson & Company: BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide.

Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

FDAOct 25, 2005Nationwide• Becton Dickinson & Company

Becton Dickinson & Company: BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide.

Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

FDAOct 25, 2005Nationwide• Becton Dickinson & Company

Boston Scientific Corporation: TLC Self -Retaining Retractor System-Single Product Code...

Sterility of device compromised due to breach in packaging

FDAOct 25, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Capio CL Kit Transvaginal Suture Capturing Device (1TLC...

Sterility of device compromised due to breach in packaging

FDAOct 25, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Precision Tack Transvaginal Sling Kit with Non-Absorbable...

Sterility of device compromised due to breach in packaging

FDAOct 25, 2005Nationwide• Boston Scientific Corporation

ela Medical Llc: Symphony DR model 2550 and ELA Rhapsody DR model 2510. A...

Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.

FDAOct 25, 2005AZ, CA, FL +7 more• ela Medical Llc

Becton Dickinson & Company: BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/...

Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

FDAOct 25, 2005Nationwide• Becton Dickinson & Company

Omron Healthcare, Inc.: Omron brand 3-Way Instant Thermometer, Model Numbers MC-6...

Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.

FDAOct 25, 2005Nationwide• Omron Healthcare, Inc.

Boston Scientific Corporation: Precision Twist Transvaginal Sling Kit with Non-Absorbabl...

Sterility of device compromised due to breach in packaging

FDAOct 25, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: TLC Retractor and Single Step Pelvic Drape (contains 1 P...

Sterility of device compromised due to breach in packaging

FDAOct 25, 2005Nationwide• Boston Scientific Corporation

ela Medical Llc: ELA Rhapsody SR model 2210. A single chamber rate-respon...

Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.

FDAOct 25, 2005AZ, CA, FL +7 more• ela Medical Llc

Gambro Renal Products, Inc.: Gambro Prisma M100 preset, Part No. 8353486.

After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

FDAOct 24, 2005Nationwide• Gambro Renal Products, Inc.

Gambro Renal Products, Inc.: Gambro Prisma HF1000 preset, Part No. 8399050.

After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

FDAOct 24, 2005Nationwide• Gambro Renal Products, Inc.

Cook, Inc.: Cook brand Zilver 635 Biliary Stent - Expanding Stent, de...

The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.

FDAOct 24, 2005CT, MI, MN +5 more• Cook, Inc.

Ossur Grjothals 5 Reykjavik Ireland: Elation, Class I Medical Device Prosthetic product, Compo...

After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.

FDAOct 21, 2005Nationwide• Ossur Grjothals 5 Reykjavik Ireland

Merit Medical Systems, Inc: Viceroy Inflation Syringe, 60mL, Sterile, Rx only.

Inflation device may not hold vacuum during angioplasty procedure.

FDAOct 21, 2005FL, OR, UT• Merit Medical Systems, Inc

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