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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00706-1
Product Name/Description	Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) Product Code: SCVPEMO01H (which includes Suction Wand Model Code: S099) Lot Numbers: CS1273342, CS1274530, CS1275921, CS1276983, CS1277145, CS1279180, CS1279527, CS1381863, CS1381982, CS1383487, CS1384082, CS1384586 and CS1385127 ARTG Number: 136870
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	11/07/2013
Responsible Entity	Medline International Two Australia Pty Ltd
Reason/Issue	Edwards Lifesciences has notified Medline that they are conducting a recall of certain lot numbers of the Edwards Lifescience Suction Wand, which is included in Medline's Cardiac Pack. Edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. The particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. Particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
Recall Action	Recall
Recall Action Instructions	Customers are asked to inspect all inventory and return affected packs to Medline.
Contact Information	1800 110 511 - Medline Customer Service