Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Reported: November 24, 2021 Initiated: October 8, 2021 #Z-0222-2022
Product Description
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 31,502 US (30,166 OUS)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.. Recalled by Cook Inc.. Units affected: 31,502 US (30,166 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0222-2022.
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