Medical Devices Recalls

Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.

Patient monitors may restart due to network overload caused by network configuration.

Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.

A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.

When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.

The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.

HVAD Battery Charger units manufactured with wrong inductors.

Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.

Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might fall on the floor. IN consequence, the patient might sustain a major trauma, head injury - damage to tissue that is irreversible or may lead to death.

The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.

Patient monitors may restart due to network overload caused by network configuration.

Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.

Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.