September 11, 2024Medical DevicesFDA
Mindray DS USA, Inc. dba Mindray North America recalls Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co
Hazard: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
September 11, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
September 11, 2024Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Hazard: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
September 11, 2024Medical DevicesFDA
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX
Hazard: Due to packaging defects, sterility assurance and heparin activity may be compromised.
September 11, 2024Medical DevicesFDA
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX
Hazard: Due to packaging defects, sterility assurance and heparin activity may be compromised.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
September 11, 2024Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f
Hazard: A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
September 11, 2024Medical DevicesFDA
Breas Medical, Inc. recalls Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati
Hazard: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
September 11, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
Hazard: Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
September 4, 2024Medical DevicesFDA
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL recalls FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Hazard: During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
September 4, 2024Medical DevicesFDA
Cypress Medical Products LLC recalls McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
Hazard: Affected syringes lack FDA clearance.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001943;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
September 4, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
Hazard: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.