Tisseel Kit; Out-of-specification (Dissolution)
Brand(s)
Last updated
Summary
Product
Tisseel Kit
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot numbers |
|---|---|---|---|---|---|
| Baxter Corporation | Tisseel Kit | DIN 02326132 | Kit | APROTININ (SYNTHETIC) 3000 KIU / ML CALCIUM CHLORIDE 40 MCMOL / ML SEALER PROTEIN (HUMAN) 125 MG / ML THROMBIN (HUMAN) 500 UNIT / ML | T5A029AB T5A055AC T5A035AA T5A002AA T5A002AB T5X048AF T5A064AB T5A033AB T5X073AB |
Issue
The dissolution time is out of specification in the affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- 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: Wholesalers, Healthcare establishments
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Biologic or vaccine
Companies
Baxter Corporation
7125 Mississauga Rd,
Mississauga, ON, L5N 0C2, Canada
Published by
Health Canada
Audience
General public
Healthcare
Hospitals
Recall class
Type II
Identification number
RA-75559
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