Medical Devices Recalls

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

Potential for exoskeleton to lose lateral balance and cause patient to fall.

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Due to a potential open seal in the sterile barrier packaging.

Inadequate weld that can potentially cause the product to disassemble.

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Due to a potential open seal in the sterile barrier packaging .

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

Due to a potential open seal in the sterile barrier packaging .

Vials of implant bone granules may contain less product then specified on labeling.

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.