CanadaEmbosphere® Microspheres‑Syringe (catalogue/model S82OGH) with lot/serial numbers X3467294-1, X3472923-A, X3482321-1, X3482321-5 and X3472987-1 is affected. Merit Medical is recalling these units because a supplier-related defect may have created a hole in the blister packaging that compromises the sterile barrier and could expose patients to pathogens/pyrogens, potentially causing infection; Merit has removed the units from the market. Owners should immediately stop using or distributing the listed lots, return the product to Merit and contact Merit Medical Canada.
What's being recalled
Companies: Biosphere Medical S.A., 383 Rue De La Belle Etoile, Roissy, France, 95700.
How to identify it
Affected products: Embosphere® Microspheres-Syringe; Lot or serial number: X3467294-1; Model or catalogue number: S82OGH
Affected products: Embosphere® Microspheres-Syringe; Lot or serial number: X3472923-A; Model or catalogue number: S82OGH
Affected products: Embosphere® Microspheres-Syringe; Lot or serial number: X3482321-1; Model or catalogue number: S82OGH
Affected products: Embosphere® Microspheres-Syringe; Lot or serial number: X3482321-5; Model or catalogue number: S82OGH
Affected products: Embosphere® Microspheres-Syringe; Lot or serial number: X3472987-1; Model or catalogue number: S82OGH
The hazard
Merit Medical Systems, Inc., on behalf of its subsidiary, Biosphere Medical, is voluntarily recalling specific lots of the Merit Embosphere® Microspheres due to a supplier-related defect that may affect the device packaging sterile barrier. Specifically, certain lots provided to Merit may contain a hole in the blister packaging. Merit has chosen to remove the units from the market and request that customers immediately stop using or distributing the affected lots and return the affected product to Merit. According to Merit's evaluation of health hazard(s), use of the affected product may result in exposure to pathogens/pyrogens, which could lead to infection. To date, Merit has not received any complaints or reports of patient harm or injury associated with this issue.
What to do
Contact Merit Medical Canada.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)