Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 83 of 138
Arrow International Inc
Class II Terminated
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1977-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1957-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1990-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP ...
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1983-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2007-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2029-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1970-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1974-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1987-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2005-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2032-2018 June 6, 2018 Reading, PA
Bard Peripheral Vascular Inc
Class II Terminated
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Reason: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheter...
Z-1802-2018 May 23, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Reason: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheter...
Z-1803-2018 May 23, 2018 Tempe, AZ
Invivo Corporation
Class II Terminated
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used ...
Reason: The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed...
Z-1867-2018 May 23, 2018 Orlando, FL
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1767-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1764-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1765-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1762-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1766-2018 May 16, 2018 Tempe, AZ
Cook Inc.
Class II Terminated
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The...
Reason: Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Z-1752-2018 May 16, 2018 Bloomington, IN
Cook Inc.
Class II Terminated
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The con...
Reason: Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Z-1754-2018 May 16, 2018 Bloomington, IN
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1771-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1761-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1770-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1763-2018 May 16, 2018 Tempe, AZ