Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 107 of 138
EKOS Corporation
Class II Terminated
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Reason: The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-...
Z-2854-2016 September 28, 2016 Bothell, WA
ICU Medical, Inc.
Class II Terminated
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...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2810-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pres...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2825-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2817-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2818-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an e...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2827-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer th...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2823-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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 ...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2819-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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 Tra...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2826-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product U...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2812-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2824-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transduce...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2813-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2820-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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 cathe...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2822-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure ...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2805-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2821-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfac...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2816-2016 September 21, 2016 San Clemente, CA
C.R. Bard, Inc.
Class II Terminated
Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Reason: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Z-2830-2016 September 21, 2016 Covington, GA
ICU Medical, Inc.
Class II Terminated
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...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2828-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2815-2016 September 21, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
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...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2811-2016 September 21, 2016 San Clemente, CA
Arrow International Inc
Class II Terminated
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Z-2772-2016 September 21, 2016 Reading, PA
Arrow International Inc
Class II Terminated
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Z-2773-2016 September 21, 2016 Reading, PA
Arrow International Inc
Class II Terminated
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requirin...
Reason: Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Z-2774-2016 September 21, 2016 Reading, PA
ICU Medical, Inc.
Class II Terminated
Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable S...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-2808-2016 September 21, 2016 San Clemente, CA