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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Siemens Medical Solutions USA

Class I - Dangerous

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

Aug 2, 2016 Infusion Pumps Nationwide View Details →

Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.

Hospira Inc., A Pfizer Company

Class I - Dangerous

Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

Jul 28, 2016 Infusion Pumps View Details →

The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

Circulatory Technology

Class I - Dangerous

The seal between the balloon and the housing may leak.

Jul 1, 2016 Patient Monitors View Details →

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Mentor Texas

Class I - Dangerous

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →

Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

Stryker Howmedica Osteonics

Class I - Dangerous

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Jun 30, 2016 Implants & Prosthetics View Details →

Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →

Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

ICU Medical

Class I - Dangerous

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Aug 10, 2016 Diagnostic Equipment Nationwide View Details →