Recall | Medicines | 08/11/2017

The marketing authorization holder informed its supplied customers in a letter dated November 8, 2017, that a production-related crack at the valve connection seal to the bag may occur in "Physioneal Clear-Flex bags". On the one hand, the crack could result in possible microbiological contamination of the solution, and on the other hand, this defect triggers a system error 2240 alarm on the HomeChoice APD device.Investigations have determined that the cause is certain batches of "Physioneal Clear-Flex bags", but the HomeChoice APD device or disposables are not affected. Thus, a recall of the defective "Physioneal Clear-Flex bags" is being implemented. In Austria, it affects a total of four batches, of which.

  1. two lots of "Physioneal 40 Glucose 1.36% w/v/13.6 mg/ml Clear-Flex - Peritoneal Dialysis Solution" (lot numbers 17E15G71, 17F06G72) and
  2. two lots of "Physioneal 40 Glucose 2.27% w/v / 22.7 mg/ml Clear-Flex - Peritoneal Dialysis Solution" (lot numbers 17E19G70, 17F12G71).
Name of the medicinal product 1. Physioneal 40 Glucose 1,36% w/v / 13,6 mg/ml Clear-Flex – Peritonealdialyselösung
2. Physioneal 40 Glucose 2,27% w/v / 22,7 mg/ml Clear-Flex – Peritonealdialyselösung
Marketing authorisation number(s) 1. 1-25588
2. 1-25589
Marketing authorisation holder Baxter Healthcare GmbH
Batch number(s) 1. 17E15G71, 17F06G72
2. 17E19G70, 17F12G71
Classification of the recall1
BASG reference number INS-640.001-2314

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