Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00741-1 |
Product Name/Description |
Clearlink System Solution Set (Infusion administration set)
Product Code: FNC3110
Lot Numbers: SR13A04021, SR13A02041, SR13A07032 (Expiration date: Jan 2018), SR13B14077 (Expiration date: Feb 2018) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
19/07/2013 |
Responsible Entity |
|
Reason/Issue |
Baxter ANZ received feedback from a customer that an IV tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. Baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. The incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario. |
Recall Action |
Recall |
Recall Action Instructions |
Baxter Healthcare are advising customers to remove affected product from use and return to Baxter for credit. |
Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |