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Showing 6561–6580 of 8389 results

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Angiography/Cath Lab Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Cysto Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Breast Abdominoplasty Pack (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Eye Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Angiography Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

C-Section Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Ethernet Cable Risk (2022)

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

FDAJun 16, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Pacemaker Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Ethernet Cable Risk (2022)

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

FDAJun 16, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Hysterectomy Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

OB/GYN Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Port Insertion Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

ENT Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Convenience Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

D&C Pack (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

SARS CoV 2 Rapid Test Kits (North American Diagnostics) – Marketing Approval Missing (2022)

Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.

FDAJun 15, 2022Nationwide• North American Diagnostics

Sensis Software (Siemens) – Communication Disconnect Risk (2022)

Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.

FDAJun 15, 2022Nationwide• Siemens Medical Solutions USA, Inc

Sensis Vibe Combo (Siemens) – Communication Disconnect Risk (2022)

Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.

FDAJun 15, 2022Nationwide• Siemens Medical Solutions USA, Inc

Sight OLO Hematology Analyzer (Sight Diagnostics) – Reference Range Error (2022)

The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.

FDAJun 14, 2022Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

Wright EVOLVE TRIAD Plate Cutter (Wright Medical) – Sterilization Issue (2022)

Laceration Risk

The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

FDAJun 14, 2022Nationwide• Wright Medical Technology, Inc.

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