November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Robotics Pack SAH, REF SAR530M
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls Breast Plastics Pack, REF BBPL20D
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls LAVH, REF BBLV21C
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
American Contract Systems, Inc. recalls General Pack, REF BBGP31C
Hazard: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110IN
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Hazard: Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
November 1, 2023Medical DevicesFDA
Omega Medical Imaging, Inc. recalls Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Hazard: An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
November 1, 2023Medical DevicesFDA
EMPATICA SRL recalls Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcar
Hazard: May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
November 1, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Hazard: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
November 1, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Hazard: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
November 1, 2023Medical DevicesFDA
Omega Medical Imaging, Inc. recalls Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Hazard: An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
November 1, 2023Medical DevicesFDA
Impedimed Limited recalls SOZO Bilateral Arm L-Dex Software
Hazard: Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.
November 1, 2023Medical DevicesFDA
Preat Corp recalls Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Hazard: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
November 1, 2023Medical DevicesFDA
Preat Corp recalls Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Hazard: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
November 1, 2023Medical DevicesFDA
Preat Corp recalls Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Hazard: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Hazard: Demonstrated recognition and compatibility issues with syringe infusion pumps.
November 1, 2023Medical DevicesFDA
GE Healthcare recalls Universal Viewer Workflow Manager, Image processing radiological system
Hazard: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
November 1, 2023Medical DevicesFDA
GE Healthcare recalls Centricity Universal Viewer Workflow Manager, Image processing radiological system
Hazard: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
November 1, 2023Medical DevicesFDA
Smiths Medical ASD Inc. recalls Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Hazard: The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
November 1, 2023Medical DevicesFDA
GE Healthcare recalls Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Hazard: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.