Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 82 of 138
Arrow International Inc
Class II Terminated
ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1985-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1991-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1993-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Prod...
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1986-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arterial Catheterization Kit; Product Codes: ASK-04020-DH
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1971-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1981-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427...
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1996-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
PICC Catheter Trimmer ; Product Code:PC-00001-T
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2020-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2011-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1980-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-4570...
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1995-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1997-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2001-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2031-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1979-2018 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 code: ASK-45703-AEH
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2003-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1984-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2002-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1982-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2008-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2000-2018 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, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-...
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2004-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arterial Catheterization Kit; Product Code:NA-04550-1A
Reason: Product sterility may be compromised due to unsealed packaging.
Z-2019-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1975-2018 June 6, 2018 Reading, PA
Arrow International Inc
Class II Terminated
SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
Reason: Product sterility may be compromised due to unsealed packaging.
Z-1962-2018 June 6, 2018 Reading, PA