Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1532-2024April 24, 2024Bloomington, IN
Cook Incorporated
Class IIOngoing
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary a...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1530-2024April 24, 2024Bloomington, IN
Cook Incorporated
Class IIOngoing
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal ...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1526-2024April 24, 2024Bloomington, IN
Cook Incorporated
Class IIOngoing
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUM...
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1527-2024April 24, 2024Bloomington, IN
Fresenius Medical Care Holdings, Inc.
Class IOngoing
stay-safe /Safe Lock Catheter Ext. 12 in
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Reason: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Z-1396-2024April 3, 2024Maple Grove, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Reason: Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This...
Z-1302-2024April 3, 2024Saint Paul, MN
Fresenius Medical Care Holdings, Inc.
Class IOngoing
stay-safe /Luer Lock Catheter Ext. 18 in
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Z-1326-2024April 3, 2024Waltham, MA
Fresenius Medical Care Holdings, Inc.
Class IOngoing
stay-safe /Luer Lock Catheter Ext. 12 in
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Z-1325-2024April 3, 2024Waltham, MA
Fresenius Medical Care Holdings, Inc.
Class IOngoing
stay-safe /Luer Catheter Ext. 6 in
Reason: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Z-1327-2024April 3, 2024Waltham, MA
ARROW INTERNATIONAL Inc.
Class IOngoing
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU;...
Reason: Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate ...
Z-1267-2024March 27, 2024Morrisville, NC
Medos International Sarl
Class IOngoing
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Reason: Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injur...
Z-1284-2024March 20, 2024Le Locle, N/A
Biosense Webster, Inc.
Class IIOngoing
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steera...
Reason: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Z-1290-2024March 20, 2024Irvine, CA
Micro Therapeutics, Inc.
Class IIOngoing
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid pro...
Reason: European version of microcatheter were distributed within US which contain a different "Indications for Use".
Z-1253-2024March 13, 2024Irvine, CA
Micro Therapeutics, Inc.
Class IIOngoing
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid pro...
Reason: European version of microcatheter were distributed within US which contain a different "Indications for Use".
Z-1252-2024March 13, 2024Irvine, CA
Medtronic Neurosurgery
Class IOngoing
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure ...
Reason: Potential for catheter disconnection from the patient line stopcock connectors.
Z-1163-2024March 6, 2024Irvine, CA
Medtronic Neurosurgery
Class IOngoing
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in...
Reason: Potential for catheter disconnection from the patient line stopcock connectors.
Z-1164-2024March 6, 2024Irvine, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1104-2024March 6, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1094-2024March 6, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND4...
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1128-2024March 6, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1107-2024March 6, 2024Northfield, IL
Medtronic Neurosurgery
Class IOngoing
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure a...
Reason: Potential for catheter disconnection from the patient line stopcock connectors.
Z-1162-2024March 6, 2024Irvine, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1130-2024March 6, 2024Northfield, IL
Medtronic Neurosurgery
Class IOngoing
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracr...
Reason: Potential for catheter disconnection from the patient line stopcock connectors.
Z-1166-2024March 6, 2024Irvine, CA
Medtronic Neurosurgery
Class IOngoing
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in...
Reason: Potential for catheter disconnection from the patient line stopcock connectors.