TGA Provides Update on Flocare Sets

January 25, 2016

Australia’s Therapeutic Goods Administration is alerting healthcare providers about a recall for product correction for Flocare transition giving with ENFit transition adaptors.

A recall for product correction involves the repair, modification, adjustment or relabeling of a product. This action does not require the return of a product.

If a transition adaptor leaks or breaks, patients may receive less feed than intended. For some patients — especially critical and/or volume sensitive patients — this can have a negative impact on their health if it is not noticed for a significant period of time.

Leakage can occur immediately after connection or over time. There have been reports outside Australia of the adaptors leaking or breaking. As of Jan. 15, one incident of this problem was reported in Australia, the TGA says.

However, the issue affects a very small number of patients who use the male luer lock and mobile giving sets, and utilize the white transition adaptor on the patient-end to connect to a luer feeding tube. — Jonathon Shacat