Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2167-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, M...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2194-2023July 26, 2023Northfield, IL
Abiomed, Inc.
Class IOngoing
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Z-2115-2023July 26, 2023Danvers, MA
Abiomed, Inc.
Class IOngoing
Impella LD intravascular micro axial blood pump, Product Number 005082
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Z-2113-2023July 26, 2023Danvers, MA
Abiomed, Inc.
Class IOngoing
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Z-2116-2023July 26, 2023Danvers, MA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTE...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2193-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI68...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2175-2023July 26, 2023Northfield, IL
Abiomed, Inc.
Class IOngoing
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Z-2111-2023July 26, 2023Danvers, MA
Abiomed, Inc.
Class IOngoing
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Reason: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destructi...
Z-2114-2023July 26, 2023Danvers, MA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; ...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2199-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model N...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2161-2023July 26, 2023Northfield, IL
Bryan Medical Inc
Class IIOngoing
Aeris Balloon Dilation Catheter
Reason: Devices were mislabeled.
Z-2148-2023July 26, 2023Cincinnati, OH
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC0114...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2195-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROB...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2156-2023July 26, 2023Northfield, IL
Abbott
Class IOngoing
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Reason: There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Z-2110-2023July 19, 2023Plymouth, MN
ARROW INTERNATIONAL Inc.
Class IOngoing
ARROW Endurance Extended Dwell Peripheral Catheter System
Reason: Potential for catheter separation or leakage
Z-1826-2023June 28, 2023Morrisville, NC
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1914-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1910-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1917-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1908-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1918-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1915-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1909-2023June 21, 2023South Jordan, UT
Merit Medical Systems, Inc.
Class IIOngoing
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Reason: There is a potential that valve assemblies will not open. preventing fluid from draining.