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Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Abbott Medical

🏥 Medical Devices Class I - Dangerous

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Jul 18, 2023 Implants & Prosthetics Nationwide View Details →

Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Abbott Medical

🏥 Medical Devices Class I - Dangerous

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Jul 18, 2023 Implants & Prosthetics Nationwide View Details →

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

Remel

🏥 Medical Devices Class I - Dangerous

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Aug 14, 2023 Other Medical Devices Nationwide View Details →

nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers

Landauer

🏥 Medical Devices Class I - Dangerous

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Jul 12, 2023 Diagnostic Equipment View Details →

Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.

Mallinckrodt Manufacturing

🏥 Medical Devices Class I - Dangerous

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

Aug 8, 2023 Patient Monitors View Details →

KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

Microbiologics

🏥 Medical Devices Class I - Dangerous

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

Aug 14, 2023 Diagnostic Equipment Nationwide View Details →

procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿ 28-GG521, l)¿¿¿¿¿¿ 28-GG521PC, m)¿¿¿ 28-GG529, n)¿¿¿¿ 28-GG553, o)¿¿¿¿ 28-GG569, p)¿¿¿¿ 28-GG571, q)¿¿¿¿ 28-GG723

Advance Medical Designs

🏥 Medical Devices Class I - Dangerous

Ultrasound gel mislabeled with inappropriate use.

Jul 7, 2023 Other Medical Devices View Details →

Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers

Landauer

🏥 Medical Devices Class I - Dangerous

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Jul 12, 2023 Diagnostic Equipment View Details →

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers

Landauer

🏥 Medical Devices Class I - Dangerous

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Jul 12, 2023 Diagnostic Equipment View Details →

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Abbott Medical

🏥 Medical Devices Class I - Dangerous

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Jul 18, 2023 Implants & Prosthetics Nationwide View Details →

nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers

Landauer

🏥 Medical Devices Class I - Dangerous

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Jul 12, 2023 Diagnostic Equipment View Details →

NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

Landauer

🏥 Medical Devices Class I - Dangerous

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Jul 12, 2023 Diagnostic Equipment View Details →

Honda Lawnmowers and Pressure Washer Engines

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The improperly manufactured camshafts in the engines can cause the starter rope to suddenly retract when pulling to start, posing an injury hazard.

Sep 14, 2023 Home & Garden Nationwide View Details →

Insignia and Yardbird fire tables with lava rocks

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The lava rocks can split and eject from the fire table, posing burn and impact injury hazards.

Sep 14, 2023 Furniture Nationwide View Details →

Chuckle & Roar Ultimate Water Beads Activity Kits

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

If a water bead is ingested, it expands and can pose ingestion, choking and intestinal obstruction hazards inside a child's body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.

Sep 14, 2023 Children's Products Nationwide View Details →

Generac Portable Generators

Generac Power Systems Inc., of Waukesha, Wisconsin

🏠 Consumer Products Class I - Dangerous

The recalled generators' fuel tank can fail to vent adequately from the rollover valve, causing the gas tank to build up excess pressure and expel fuel when opened, posing fire and burn hazards.

Sep 14, 2023 Furniture Nationwide View Details →