Physioneal
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.
- two lots of "Physioneal 40 Glucose 1.36% w/v/13.6 mg/ml Clear-Flex - Peritoneal Dialysis Solution" (lot numbers 17E15G71, 17F06G72) and
- 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 recall | 1 |
| BASG reference number | INS-640.001-2314 |
Further inquiry note
Page last modified:
12/07/2022