PharmacovigilanceOfficial

Health Canada flags leak risk in Fresenius Kabi sodium citrate apheresis bags but stops short of recall

🇨🇦 Health Canada · Tue 03 Nov 2026

Certain lots of Fresenius Kabi Canada's anticoagulant sodium citrate 4g/100mL have manufacturing-related leak defects; Health Canada advises bag-by-bag checks rather than withdrawal.

Health Canada has issued a health professional risk communication on certain lots of Fresenius Kabi Canada Ltd's Anticoagulant Sodium Citrate Solution, USP 4g/100mL (250mL bags, DIN 02529637), which may leak because of manufacturing-related defects. The affected lot numbers are listed in an appendix to the notice. A leaking bag could cause loss of anticoagulant, interrupt the apheresis procedure, or allow microbial contamination of the solution.

The company reports that the leaks stem from sealing defects, lamination issues, channel leaks and leaks at the twist-off (butterfly) port. No design-related defect has been identified. Affected lots were distributed in Canada from 30 December 2025, and Fresenius Kabi says it is putting corrective and preventative measures in place to prevent recurrence.

The lots are not being recalled. Health Canada, in consultation with the company, concluded that risk mitigation measures can detect leaking bags before use, and that a recall could significantly disrupt plasma collection operations. Fresenius Kabi has so far received no reports of adverse events and no complaints about possible microbiological contamination with the affected lots.

The product is a sterile, non-pyrogenic, single-use solution for use with apheresis devices only and is not intended for direct intravenous infusion. Health Canada is asking the company to ensure that all affected healthcare professionals and handling personnel receive the communication, and says it is monitoring any further corrective actions. It will act and inform Canadians if additional safety information emerges.

What it means for your team

  • Apply the label-directed check to every bag, whatever the lot: remove the overwrap and squeeze the inner bag firmly to look for small leaks.
  • Discard any bag that is leaking, damaged or contains solution that is not clear, as sterility may be impaired; report leaks, damage or other quality concerns to Fresenius Kabi Canada.
  • Quality and inventory teams should check the appendix of lot numbers and pass the notice on to relevant staff and any consignees supplied through their organisation.
  • The absence of a recall shows regulators weighing supply continuity for plasma collection against a defect that can be detected before use; the case rests on inspection being carried out reliably.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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