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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00796-1
Product Name/Description	Bard PowerPICC kits 5 FR, DL, PowerPICC Solo Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Catalog No: 22295118 Lot No's: REHY2817 , REHZ1868, REJN4151 6Fr, TL, PowerPICC Solo Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Catalog No: 22386118 Lot No: REHY2801 6Fr, TL, PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Catalog No: 22396118 Lot No's: REHX2164, REHY1653, REJN1069 ARTG's: 301651 & 301652
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/09/2024
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	BBraun SafeCan Introducer Needles were replaced with SecureLoc Safety Introducer Needles in specific lots of the PowerPICC kits. This change from the old BBraun SafeCan Introducer Needle to the new BD SecureLoc Safety Introducer Needle has not been assessed by the European Union (EU) Notified Body (NB). However, the affected PowerPICC kits were distributed as CE-marked product prior EU NB assessment of the change. The changed kits are therefore considered not approved for use in Australia. The impacted products are labelled with a splash sticker which was added to the packaging stating “This kit contains the Secureloc safety introducer needle” informing the potential user of the change.
Recall Action	Recall
Recall Action Instructions	Inspect stock and ensure any remaining devices are identified and discarded. A credit will be issued for any affected stock.
Contact Information	(02) 8875 7000 - BD