OFFICIAL-SOURCE RECALL · AUSTRALIA
GYNECARE TVT EXACT Continence System Recall: Classification Class III Reason for the Action The
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- GYNECARE TVT EXACT Continence System
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Why this product was recalled
Classification Class III Reason for the Action The manufacturer, Ethicon SARL, has identified a problem whereby white particulates were observed within the sterile barrier of certain LOTs. The manufacturer has determined that the white particulates originated from the adhesive layer applied to the Tyvek lid on the product packaging. The white particulates are visible to the naked eye during package inspection and opening in the operating room by trained personnel. The particulates are mainly located within the package blister and come from packaging materials. These materials are not cytotoxic, not genotoxic, and not expected to sensitise or irritate or be systematically toxic. While there is a potential for particulates to transfer to the TVT EXACT tape, it is unlikely to affect device functionality. Surgical delay may occur if a surgeon opts not to use the product, but there is no expected direct harm associated with this problem. Instructions for Customers/Users Customers are to: - Inspect stock and quarantine any
Hazard
Classification Class III Reason for the Action The manufacturer, Ethicon SARL, has identified a problem whereby white particulates were observed within the sterile barrier of certain LOTs. The manufacturer has determined that the white particulates originated from the adhesive layer applied to the Tyvek lid on the product packaging. The white particulates are visible to the naked eye during package inspection and opening in the operating room by trained personnel. The particulates are mainly located within the package blister and come from packaging materials. These materials are not cytotoxic, not genotoxic, and not expected to sensitise or irritate or be systematically toxic. While there is a potential for particulates to transfer to the TVT EXACT tape, it is unlikely to affect device functionality. Surgical delay may occur if a surgeon opts not to use the product, but there is no expected direct harm associated with this problem. Instructions for Customers/Users Customers are to: - Inspect stock and quarantine any
Official recall notice
GYNECARE TVT EXACT Continence System
Agency: Therapeutic Goods Administration
Official publication date: July 31, 2026
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