Z-0223-2022 Class II Terminated
FDA device recall Z-0223-2022 was initiated by Cook Inc. on October 8, 2021 and is designated Class II. 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… The recall status is terminated (terminated February 14, 2024). Affected quantity: 4789 (OUS only).
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- October 8, 2021
- Termination Date
- February 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4789 (OUS only)
Product Description
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
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