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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00541-1
Product Name/Description	ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles Product codes: BMHN1304VX, DBMNI1501, DBMNI1601, DBMNJ0804TL, DBMNJ1104TL, DBMNI1601 Lot Numbers: 11095380, 11095842, 11098707, 11089370, 11096115, 11088295, 11094182, 11088597, 11090527 ARTG Number: 223222
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/06/2015
Responsible Entity	Culpan Medical Pty Ltd
Reason/Issue	Some of these products may have a hole in the blister pack, which may compromise the sterility of the product inside the tray. Invasive medical procedures conducted using non-sterile products could result in an infection for the patient. To date, there have been no reports of patient harm or infection attributed to this issue.
Recall Action	Recall
Recall Action Instructions	Customers are asked to check their inventory and place affected stock into quarantine. Culpan Medical will arrange to have quarantined stock collected. Unaffected products are available to replace any returned units. This action has been closed-out on 08/08/2016.
Contact Information	1800 820 193 Culpan Medical