Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 87 of 138
Medical Components, Inc dba MedComp
Class II Terminated
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extens...
Reason: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Z-1123-2018 March 28, 2018 Harleysville, 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. Permits venous a...
Reason: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of be...
Z-1161-2018 March 28, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Reason: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of be...
Z-1164-2018 March 28, 2018 Reading, PA
Medical Components, Inc dba MedComp
Class II Terminated
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where t...
Reason: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Z-1118-2018 March 28, 2018 Harleysville, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introducti...
Reason: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of be...
Z-1159-2018 March 28, 2018 Reading, PA
Boston Scientific Corporation
Class II Terminated
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collect...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1099-2018 March 28, 2018 Marlborough, MA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditio...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1000-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring c...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0999-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or cond...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1004-2018 March 21, 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 Usage: The Arrow¿ CVC is indicated t...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0995-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) ...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0996-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring ...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0998-2018 March 21, 2018 Reading, PA
Medtronic Minimally Invasive Therapies Group
Class II Terminated
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Reason: Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following noti...
Z-1007-2018 March 21, 2018 Mansfield, MA
Cook Inc.
Class II Terminated
Left Atrial Catheter Set
Reason: Label does not state that the product is heparin-coated.
Z-0965-2018 March 21, 2018 Bloomington, IN
Arrow International Inc
Class II Terminated
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiri...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1001-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring ...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1003-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0994-2018 March 21, 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) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) cent...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-0997-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access includin...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1002-2018 March 21, 2018 Reading, PA
Arrow International Inc
Class II Terminated
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or condi...
Reason: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1005-2018 March 21, 2018 Reading, PA
Cook Inc.
Class II Terminated
Central Venous Catheter Tray
Reason: Label does not state that the product is heparin-coated.
Z-0964-2018 March 21, 2018 Bloomington, IN
Stryker Sustainability Solutions
Class II Terminated
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Cathete...
Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Z-0917-2018 March 14, 2018 Tempe, AZ
Stryker Sustainability Solutions
Class II Terminated
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Cathete...
Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Z-0916-2018 March 14, 2018 Tempe, AZ
Medtronic Neuromodulation
Class II Ongoing
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system...
Reason: Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
Z-0896-2018 March 14, 2018 Minneapolis, MN
ConMed Corporation
Class II Terminated
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravi...
Reason: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Z-0804-2018 March 7, 2018 Utica, NY