규제 업데이트

Sanofi-Aventis Canada is recalling 1,043 insulin pens and cartridges from ~80 Canadian sites after they may have been frozen during shipping, potentially reducing effectiveness.

Health Canada recalls nine Sarclisa single-use vials from three Nova Scotia locations after possible freezing during shipment.

Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.

Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.

Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.

Baxter Corp. has issued an urgent correction for its Likorall™ ceiling‑mounted patient lift due to potential motor shaft breakage and reduced safety system performance, which may cause the lift strap to descend faster than expected.

Baxter Corp. alerts users of a potential motor shaft breakage and reduced safety system performance in Likorall™ ceiling lifts, which may cause straps to lower faster.

Cook Medical reports that certain cystoscopic injection needle lots may have a misaligned female luer lock adapter.

Health Canada warns that IMAAVY solution lots JNYJ1202 and JNYJ1206 may contain glass particles; recall limited to healthcare establishments.

STERIS reports that some RAPICIDE™ Part A bottles may bulge due to blocked vent caps, posing a risk of off‑gassing and exposure if PPE is not used.

A small number of RAPICIDE™ Part A bottles may bulge due to blocked vent caps, potentially releasing vapor and exposing users; STERIS will notify affected consignees and provide replacements.

Trinity Biotech is recalling Oxalate Reagent B (Product Code 591-2, Lot 2500711) because of performance variability causing negative bias and under‑recovery of oxalate values, potentially yielding falsely low patient results.