Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems
Class I - Dangerous
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Fresenius Medical Care Holdings
Class I - Dangerous
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
Philips North America
Class I - Dangerous
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
OptumHealth Care Solutions
Class I - Dangerous
Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Fresenius Medical Care Holdings
Class I - Dangerous
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
Philips North America
Class I - Dangerous
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries
Class I - Dangerous
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
Philips North America
Class I - Dangerous
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).