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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