Medical Devices Recalls

Device is breaking while in use, potential for patients to require a revision surgery.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

There is a potential for blood backfill leakage and foreign material.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Potential PCBA leaching from tubing of hemodialysis machines.

Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.

Some surgical glove sterile pouches were not completely sealed.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.