Cook recalls transseptal needles with potential rust on interior/exterior that may cause inflammatory reactions, systemic reactions, or permanent impairment. Affected items have specific UDI codes listed in the recall notice.
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.
Cook is recalling transseptal needles that may have rust on the interior or exterior surfaces. This could lead to inflammatory reactions, systemic reactions, or permanent impairment during medical procedures. Affected products have specific UDI codes listed in the recall notice.
Rust on the needle surfaces may cause inflammatory reactions, systemic reactions, or permanent impairment during medical procedures
Medical professionals using transseptal needles for procedures
UDI codes starting with 00827002023642(17) followed by 10 digits
The UDI code is a 17-digit code followed by 10 digits (e.g., 00827002023642(17)1000000000)
Rust on the needle surfaces may cause inflammatory reactions, systemic reactions, or permanent impairment during medical procedures.
Check if your needle has a UDI code starting with 00827002023642(17) followed by 10 digits.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0222-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-0222-2022 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
