BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L

GIF decision: Withdrawal from market

What does this decision mean?

• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.

Potential quality defect of the primary packaging, which may affect the safety and quality of the peritoneal dialysis solution. Potential effects: complications during dialysis, infections, lack of treatment efficacy.

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BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L

Risk Level

Critical

Manufacturer

Fresenius Medical Care Deutschland GmbH, Niemcy

Batch Number

A2LF261

Notice Date

16.09.2019

What to do if you have this product?

A recall means the product may be unsafe. Here is what to do if you have it at home.

1

Do not eat or use the product

Stop using or consuming it immediately and keep it out of reach of children.
2

Check the batch number and expiry date

Compare the batch/lot number and the best-before or expiry date with the details in the alert — sometimes only specific batches are affected.
3

Return it to the shop

You can take the product back to the shop where you bought it. For a safety recall a refund is due even without a receipt.
4

Get help and report it

If you feel unwell after using the product, contact a doctor. You can also report the case to the relevant authority — GIS, GIF or UOKiK.

General guidance for recalled products in Poland. Always follow the specific instructions in the official alert and from the manufacturer or retailer.

Important Information

What You Should Know

Recommendations

Do not use the product from batch A2LF261 after the expiry date 05.2021; patients should contact their physician or dialysis center to verify the product they use and obtain a replacement.

Actions Taken

The Chief Pharmaceutical Inspector withdrew from the market throughout the country the medicinal product bicaVera with 1.5% glucose and calcium 1.25 mmol/l, peritoneal dialysis solution, batch number ...

Need Help?

If you feel unwell after consuming this product, contact your doctor or call the poison control center.

BICAVERA Z 1,5% GLUKOZĄ I WAPNIEM 1,25 MMOL/L

What to do if you have this product?

What You Should Know

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Actions Taken

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