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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