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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00882-1
Product Name/Description General Laparoscopy Procedure Pack and Gynaecological Laparoscopy Procedure Pack containing CORE Suction Irrigation Handpiece (sterile)

General Laparoscopy Procedure Pack
Product Codes: CSBABRMQ18A and CSBABRMQ18B

Gynecological Laparoscopy Procedure Pack
Product Codes: CSMABRMQ10A and CSMABRMQ10B

ARTG Number: 137395
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/07/2016
Responsible Entity Medline International Two Australia Pty Ltd
Reason/Issue This letter is to inform users that Medline is recalling two procedure packs, the General Laparoscopy and the Gynecological Laparoscopy, as they contain a ConMed CORE Suction Irrigation Handpiece. Medline was informed by ConMed that the CORE Suction Irrigation Handpiece may contain creases in the packaging seal which sometimes results in an open channel. These channels may compromise sterility of the product. There have been no reports of injuries as a result of this issue.
Recall Action Recall
Recall Action Instructions Medline is advising users to check the procedure packs in stock, remove and retain the ConMed CORE suction Irrigation Handpiece for return. Medline will replace the affected handpieces with unaffected stock.
This action has been closed-out on 20/01/2017.
Contact Information 1800 110 511 - Medline Customer Service Team