Sodium chloride
Recall
|
Medicines
|
27/02/2014
The marketing authorization holder informed its supplied customers in a letter dated February 25, 2014, that increased customer complaints have been received regarding leaks at the emoluer connection of Clear-Flex pouches. Investigations have shown a defect in the female luer lock connector. This damage can result in the need for increased force to screw the Luer Lock connector onto the Clear-Flex pouch Emoluer. As a consequence, there is an increased risk of leakage if the Luer Lock connector is not completely screwed in place:
- Recall of the affected batches, as the alternative product "Isotonic Saline "Serumwerk" 0.9% Infusion Solution", Z.Nr. 1-23718, can be used.
- If the alternative product cannot be used, based on the risk/benefit ratio for the patient/recipient, the product may continue to be used until a substitute is obtained and in compliance with safety precautions attached below.
| Name of the medicinal product | Natrium chloratum physiolog. "Baxter" -Infusionslösung |
|---|---|
| Marketing authorisation number(s) | 15.556 |
| Marketing authorisation holder | Baxter Healthcare GmbH |
| Batch number(s) | 13J0208, 13J2304, 13J2305, 13J2405, 13J2406, 13K1402, 13L1206, 14A1507 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1030 |
Further inquiry note
Page last modified:
12/07/2022