Cook recalls Check-Flo Performer Introducer Sets with reference part number RCF-5.0-35-45-J due to white caps potentially disconnecting, which could cause medical complications during use.
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Cook is recalling Check-Flo Performer Introducer Sets that may have white caps disconnecting. This could lead to medical complications during procedures if the device becomes dislodged.
The white caps that connect the shaft to the hub can disconnect during use. This could cause the device to become dislodged, potentially leading to medical complications during procedures.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices during surgery may be affected if the device disconnects.
Check for the reference part number RCF-5.0-35-45-J or order number G27242 on the product. These devices were sold with lot number 15506769.
Inspect the white caps for signs of disconnection or looseness.
Cook is recalling these devices due to complaints that the white caps may disconnect during use, which could cause medical complications.
The recall does not specify a remedy, so check the device for disconnection and contact Cook for further guidance.
The recall mentions potential medical complications but does not specify serious injury risks, so the risk level is low.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0045-2025 — Cook Cook Hello, I own a Cook that is covered by recall Z-0045-2025 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.
