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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00113-1
Product Name/Description Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging

Product Code: H93866025

All lot numbers with expiration date 10/2014 to 10/2017

ARTG number: 217859
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 5/03/2015
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue Baxter Healthcare identified that the affected products (Self-Righting Luer Slip and Luer Lock Tip Caps ) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. The heat shrink tape used on the DISCPAC package is the only product component that contains latex. The Instructions for Use (IFU) correctly identifies the content of latex. Unintended or accidental exposure to latex has the potential to elicit a hypersensitivity reaction, especially in sensitised individuals. Symptoms may range from skin irritation to anaphylaxis. Baxter has not received any reports of adverse events associated with this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Baxter is alerting its customers of this labelling issue of missing latex symbol in an effort to prevent unintended exposure to latex. Baxter is updating the labelling of the affected products to include the latex symbol for future batches. This action has been closed-out on 02/03/2016.
Contact Information 02 9848 1111 - Baxter Healthcare