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FDAOctober 8, 2021device

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

What to do

FDA enforcement status: Terminated

Brands named

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UPCs

0082700202364200827002023659

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator. — Recall Details · AllClear