Baxter recalls one lot of DIANEAL peritoneal dialysis solution due to the potential presence of particulate matter

Starting date:
January 18, 2018
Posting date:
January 18, 2018
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-65750

Issue

Health Canada is advising Canadians that Baxter Corporation is voluntarily recalling one lot of DIANEAL PD4 1.5% peritoneal dialysis solution in the 5-litre bag format due to the potential presence of particulate matter within the connectors.

DIANEAL is a sterile peritoneal dialysis solution used for patients whose kidneys are not working properly. The dialysis solution is used in hospitals and home settings.

Products affected

  • DIANEAL, PD4 1.5% 5L SYSII (DIN 00865095) - Lot number W7K16T1B
  • The recall affects 10 units of one lot that were distributed between December 5, 2017 and January 9, 2018.

What you should do

  • Immediately examine your stock to determine whether you have product from the affected lot. If any is found, speak to your healthcare provider immediately regarding replacement product.
  • Contact Baxter Corporation Customer Care at 1-866-968-7477 for instructions on how to return the recalled product.
  • Talk to your doctor or nurse if you have used product from the affected lot.
  • Report adverse events to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

Canadians who have product from the affected lot.

Background

Patients run the DIANEAL peritoneal dialysis solution through a catheter that passes through the abdominal wall into the peritoneal cavity (the space between the abdominal wall and the internal organs). The peritoneal cavity is lined by a thin membrane called the peritoneum. Waste products and water are filtered through the peritoneum into the dialysis solution which is then drained through the catheter and discarded.

Undetected particulate matter may enter the peritoneal cavity when the dialysis solution is flushed in. While the particulate matter will be most likely flushed out when the fluid is drained, it is possible that some particles may remain in the peritoneal cavity. If this happens, these particles may cause a local inflammatory reaction or a type of peritonitis (inflammation of the peritoneum) that is not related to infection. This type of peritonitis cannot be treated with antibiotics, and can sometimes persist, or recur at a later date.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada is monitoring the recall. Should Health Canada become aware of additional safety information, it will take appropriate action and inform Canadians as necessary.

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