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Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Baxter…

Affected lots may contain the presence of Cronobacter contamination.

Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility assurance level cannot be guaranteed. Recall start date:…

Non-licensed inventory was sent to Canada via web shop orders starting in February of 2022. Recall start date: December 12, 2022

Affected lots may contain the presence of foreign matter.

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured…

Beckman Coulter has determined that the Access 2 wash arm lead screw nut band is susceptible to breakage. An Access 2 Immunoassay system wash arm may not move as intended if the nut band is broken. A broken nut band may increase the risk of erroneous…

Summit Medical received a customer complaint that Nasal Septal Button, 5cm, SP-78105 parts received from lot# 219349 were in unsealed pouched. The product was sterilized, but if this sterile barrier is not sealed, there is a possibility of product…

There is a potential malfunction with the side-port of the Triever 24. The side-port may potentially leak or dislodge during device preparation or during actual use. The side-port of the triever24 catheter is used in combination with a 60cc large bore…

BVI has received a complaint from a customer that catalog # 376630 of the Beaver Edgehead Stiletto/Mvr knife 0.90 mm Straight (20g), a component of the Readpak kit (cat:584896, lots:6054175,6053035), was shipped with an open head. BVI is recalling the…

Cardinal Health has initiated a medical device correction for specific production lots of the Cardinal Health™ Jackson-Pratt™ channel drains. The recall is being issued due to various performance issues including lack of radiopacity in wound drains, dull…

The manufacturer of Statis SL handpieces has informed SciCan that the product may not function as expected if not properly maintained. When using the Statis handpieces, the lack of care or age-related wear and tear could result in the loosening parts…

In case the magnets of the Novastar TS and Novastar Plus are positioned near medical devices (implanted as well as not-implanted) and metallic implants the magnetic field might impact the implants or devices and cause serious injury. Recall start date…

Manufacturer initiated recall notifying users of variability of only the level 1 troponin I values included in the Mas CardioImmune XL controls (confirmed after 8 complaints). The level 1 control is included in lots of control kits CAI-XL 1, CAI-XL4…

The catheter repair adhesive used to attach the repair segment to the original catheter is hardened/coagulated (unusable). Recall start date: January 4, 2023