Belzer MPS and Belzer UW: Particulate matter
Last updated
Summary
Product
Belzer MPS UW Machine Perfusion Solution and Belzer UW Cold Storage Solution
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Belzer MPS UW | Belzer MPS Machine Perfusion Solution | No market authorization | Solution | Calcium chloride (dihydrate) 0,5 mmol/l, HEPES (free acid) 10 mmol/l, Potassium phosphate (monobasic) 25 mmol/l, Mannitol (USP) 30 mmol/l, Glucose (anhydrous), beta D (+) 10 mmol/l, Sodium gluconate 80 mmol/l, Magnesium gluconate (anhydrous) 5 mmol/l, Ribose, D (–) 5 mmol/l, Pentafraction (HES) 50 g/l, Glutathione (reduced form) 3 mmol/l, Adenine (free base) 5 mmol/l | 121621, 121721 |
| Belzer UW | Belzer UW Cold Storage Solution | No market authorization | Solution | Pentafraction (HES) 50 g/l, Lactobionic Acid (as Lactone) 105 mmol/l, Potassium Phosphate monobasic 25 mmol/l, Magnesium Sulfate heptahydrate 5 mmol/l, Raffinose pentahydrate 30 mmol/l, Adenosine 5 mmol/l, Allopurinol 1 mmol/l, Total Glutathione 3 mmol/l, Potassium Hydroxide 100 mmol/l | 010322, 021822, 030222, 030422, 030722, 030822, 030922, 123021 |
Issue
Presence of particulate matter in affected lot.
What you should do
- Verify if your product is affected.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of Recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Recalling firm:
Bridge to Life Ltd. 128 Suber Road, Columbia, South Carolina 29210, USA
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-72596
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