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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00132-1
Product Name/Description	Neonatal ArcticGel Pads Catalog Number: 31802, 3180202, 31802C Lot Number: NGGZ2622, NGGV1829, NGHQ2940 ARTG 262560 (Bard Australia Pty Ltd - Heating unit, pad, water)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/02/2024
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	The reduced water flow in the Neonatal ArcticGel Pad has the potential to reduce or prevent water heater function within the Arctic Sun system. Investigation identified the production acceptance criteria for the flow rate of Neonatal ArcticGel Pads (product codes 318-02, 318-02-02, and 318-02C) may be unacceptably low, equating to acceptance criteria of 0.49 L/min, which does not match the IFU specified flow rate of 1.1 L/min. The defect has the potential to result in severe symptoms, serious injury, and/or long-term risk to health, such as exacerbation of known hypothermia, arrythmia, electrolyte imbalance, and skin damage. There is also a potential for delay in therapy and therapy prolongation that requires either a replacement device or alternative device to continue with patient therapy. BD (Bard) has received increasing complaints since February 2023. There have been no adverse events associated with this defect.
Recall Action	Recall
Recall Action Instructions	1. Immediately discontinue use. 2. Please check all inventory locations within your institution for the product listed above and immediately dispose of all affected product remaining in your possession in accordance with your local facility’s process.
Contact Information	1800 656 100 - BD