Abbott Medical recalls Fast-Cath Hemostasis Introducers with 8F instead of 8.5F dilators. These devices may cause improper vessel access during procedures. Affected batches include 6917183, 6950628, and 7099144.
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Abbott Medical is recalling Fast-Cath Hemostasis Introducers that contain 8F-sized dilators and sheaths instead of the required 8.5F devices. Using these incorrect sizes could lead to improper vessel access during medical procedures.
The recalled devices include 8F-sized dilators and sheaths instead of the required 8.5F devices. This mismatch could cause improper vessel access during medical procedures, potentially leading to complications.
Healthcare professionals using the Fast-Cath Hemostasis Introducer for medical procedures are most at risk. Patients undergoing procedures with these devices may experience complications due to incorrect sizing.
Check the batch numbers on the device: 6917183, 6950628, or 7099144. The product is labeled as Fast-Cath Hemostasis Introducer, 8.5F, 2.83 mm, REF 406143.
Look for batch numbers 6917183, 6950628, or 7099144 on the device's UDI label.
The recalled devices contain 8F-sized dilators and sheaths instead of the required 8.5F devices, which could cause improper vessel access during medical procedures.
Batches 6917183, 6950628, and 7099144 are affected.
Check the batch number on the device's UDI label. If it matches one of the affected batches, contact Abbott Medical for further instructions.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0789-2020 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0789-2020 from Abbott Medical. 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.
