October 18, 2023Medical DevicesFDA
Beckman Coulter, Inc. recalls Access Thyroglobulin Calibrators
Hazard: It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
October 18, 2023Medical DevicesFDA
Alcon Research, LLC recalls Constellation Vision System, REF: 8065751150
Hazard: Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
October 18, 2023Medical DevicesFDA
Encore Medical, LP recalls REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Hazard: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
October 18, 2023Medical DevicesFDA
Ansell Healthcare Products LLC recalls NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Hazard: Some surgical glove sterile pouches were not completely sealed.
October 18, 2023Medical DevicesFDA
Ansell Healthcare Products LLC recalls GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Hazard: Some surgical glove sterile pouches were not completely sealed.
October 18, 2023Medical DevicesFDA
Advance-Esthetic LLC recalls MED-810A Zemits NDPrime Laser products
Hazard: Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.
October 18, 2023Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desk
Hazard: When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Ant
Hazard: XXX
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Pre
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2)
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Pres
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile;
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource
Hazard: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
October 18, 2023Medical DevicesFDA
RoyalVibe Health Ltd. recalls CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restruct
Hazard: Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established. There is a possibility of customers' reliance on marketing claims which could cause the user to forgo medical treatment resulting in health consequences.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Hazard: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
October 18, 2023Medical DevicesFDA
Flower Orthopedics Corporation recalls Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary
Hazard: Device is breaking while in use, potential for patients to require a revision surgery.
October 18, 2023Medical DevicesFDA
LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85
Hazard: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. W/O CDX BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. CDX W/BIBAG BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.
October 18, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 2008T HD SYS. CDX BLUESTAR
Hazard: Potential PCBA leaching from tubing of hemodialysis machines.