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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Transpac IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42642-06 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code JJY·October 12, 2016

RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXD·October 11, 2016

TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 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.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016