December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialys
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Hazard: There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
December 4, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Us
Hazard: Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
December 4, 2024Medical DevicesFDA
Remote Diagnostic Technologies Ltd. recalls Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man
Hazard: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
December 4, 2024Medical DevicesFDA
Shimadzu Corp. Analytical & Measuring Instruments Div. recalls Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
Hazard: There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.
December 4, 2024Medical DevicesFDA
Shimadzu Corp. Analytical & Measuring Instruments Div. recalls Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
Hazard: There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.
December 4, 2024Medical DevicesFDA
Abbott Medical recalls Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capa
Hazard: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
December 4, 2024Medical DevicesFDA
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p
Hazard: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
December 4, 2024Medical DevicesFDA
GE Healthcare (China) Co., Ltd. recalls GE Proteus XR/A radiographic system
Hazard: Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
December 4, 2024Medical DevicesFDA
INCIPIO DEVICES recalls Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Hazard: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls ST SENSE Breast Dx Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls ST SENSE Breast Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls SENSE Breast Coil 3.0T 7ch
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls SENSE Breast Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Interventional Coil 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Diagnostic Coil 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Interventional Coil 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Diagnostic Coil 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 7ch 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 7ch 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 16ch 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 16ch 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.