MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DY...
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-1097-2024March 6, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,...
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-1096-2024March 6, 2024Northfield, IL
United Orthopedic Corporation
Class IIOngoing
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153...
Reason: Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1216-2024March 6, 2024Hsinchu
United Orthopedic Corporation
Class IIOngoing
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE2...
Reason: Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1217-2024March 6, 2024Hsinchu
IMPULSE DYNAMICS (USA) INC
Class IIOngoing
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Reason: OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to befor...
Z-1173-2024February 28, 2024Marlton, NJ
W.L. Gore & Associates, Inc.
Class IIOngoing
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Reason: Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unp...
Z-1179-2024February 28, 2024Elkton, MD
BALT USA, LLC
Class IIOngoing
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral va...
Reason: Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold...
Z-1042-2024February 14, 2024Irvine, CA
BALT USA, LLC
Class IIOngoing
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o...
Reason: Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold...
Z-1041-2024February 14, 2024Irvine, CA
American Contract Systems, Inc.
Class IIOngoing
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0818-2024February 7, 2024Temple Terrace, FL
Medtronic Neuromodulation
Class IIOngoing
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Reason: Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (...
Z-0780-2024January 31, 2024Minneapolis, MN
Medtronic Inc.
Class IIOngoing
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Reason: During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice...
Z-0779-2024January 31, 2024Mounds View, MN
Waldemar Link GmbH & Co. KG (Mfg Site)
Class IIOngoing
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Reason: Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resec...
Z-0749-2024January 24, 2024Norderstedt, N/A
Limacorporate S.p.A
Class IIOngoing
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degre...
Reason: Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its origina...
Z-0726-2024January 24, 2024San Daniele Del Friuli, N/A
Icotec Ag
Class IIOngoing
VADER pedicle system, torque wrench, Catalog Number 42-703
Reason: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th...
Z-0701-2024January 17, 2024Altstatten Sg
Boston Scientific Corporation
Class IIOngoing
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ...
Reason: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Z-0673-2024January 17, 2024Saint Paul, MN
Icotec Ag
Class IIOngoing
VADER pedicle system, torque wrench, Catalog Number 42-702
Reason: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th...
Z-0700-2024January 17, 2024Altstatten Sg
ResMed Ltd.
Class IOngoing
AirTouch N20 Nasal Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0540-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirFit F30 Full Face Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0541-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirFit F30i Full Face Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0542-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirFit F20 Full Face Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0537-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirFit N20 Nasal Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0539-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirTouch F20 Full Face Mask and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0538-2024December 27, 2023Bella Vista, N/A
ResMed Ltd.
Class IOngoing
AirFit N10 Nasal Masks and User Guide
Reason: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and ...
Z-0536-2024December 27, 2023Bella Vista, N/A
Heartware, Inc.
Class IIOngoing
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...