Reason: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Z-1271-2018April 4, 2018Harleysville, PA
Cook Inc.
Class IITerminated
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24...
Reason: Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable ga...
Z-1188-2018April 4, 2018Bloomington, IN
Boston Scientific Corporation
Class IITerminated
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reason: Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Z-1133-2018March 28, 2018Marlborough, MA
Boston Scientific Corporation
Class IITerminated
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1102-2018March 28, 2018Marlborough, MA
Merit Medical Systems, Inc.
Class IITerminated
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Reason: 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Z-1145-2018March 28, 2018South Jordan, UT
Arrow International Inc
Class IITerminated
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Perm...
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-1160-2018March 28, 2018Reading, PA
Medical Components, Inc dba MedComp
Class IITerminated
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repai...
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-1120-2018March 28, 2018Harleysville, PA
Medical Components, Inc dba MedComp
Class IITerminated
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repa...
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-1124-2018March 28, 2018Harleysville, PA
Boston Scientific Corporation
Class IITerminated
Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the ...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1104-2018March 28, 2018Marlborough, MA
Centurion Medical Products Corporation
Class IITerminated
CATHETER SECUREMENT SYSTEM
Reason: Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Z-1083-2018March 28, 2018Williamston, MI
Medical Components, Inc dba MedComp
Class IITerminated
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where the...
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-1126-2018March 28, 2018Harleysville, PA
Vascular Insights, LLC
Class IITerminated
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
Reason: Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction ...
Z-1146-2018March 28, 2018Quincy, MA
Arrow International Inc
Class IITerminated
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access t...
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-1163-2018March 28, 2018Reading, PA
Boston Scientific Corporation
Class IITerminated
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1100-2018March 28, 2018Marlborough, MA
Medical Components, Inc dba MedComp
Class IITerminated
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repa...
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-1122-2018March 28, 2018Harleysville, PA
Arrow International Inc
Class IITerminated
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and ca...
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-1158-2018March 28, 2018Reading, PA
Boston Scientific Corporation
Class IITerminated
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1103-2018March 28, 2018Marlborough, MA
Arrow International Inc
Class IITerminated
Pressure Injectable Multi- 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-1162-2018March 28, 2018Reading, PA
Arrow International Inc
Class IITerminated
Pressure Injectable Multi- Lumen CVC Kit
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...
Reason: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Z-1143-2018March 28, 2018South Jordan, UT
Arrow International Inc
Class IITerminated
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femor...
Reason: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
Z-1152-2018March 28, 2018Reading, PA
Boston Scientific Corporation
Class IITerminated
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated...
Reason: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Z-1101-2018March 28, 2018Marlborough, MA
Medical Components, Inc dba MedComp
Class IITerminated
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repai...
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-1121-2018March 28, 2018Harleysville, PA
Merit Medical Systems, Inc.
Class IITerminated
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Reason: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Z-1144-2018March 28, 2018South Jordan, UT
Arrow International Inc
Class IITerminated
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the 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...