Cook recalls Check-Flo Performer Introducer with longer sheaths that may cause injury during use. Affected units include specific catalog and lot numbers. Consumers should contact Cook for details.
The products were manufactured with longer than specified sheaths.
Cook is recalling a specific model of Check-Flo Performer Introducer due to sheaths that are longer than specified. This could lead to injury if the device is used improperly. The recall affects a limited number of units with a specific catalog and lot number.
The sheaths are longer than specified, which could cause the device to move unexpectedly during use. This might lead to injury if the device slips or becomes dislodged. The hazard is not severe enough to cause serious injury in normal use but requires careful handling.
Users of the Check-Flo Performer Introducer with catalog number RCFW-5.0-25-45-RB-CHB and lot number 8858425 are affected. Medical professionals using this device for procedures are most at risk due to potential injury from improper use.
Check for the catalog number RCFW-5.0-25-45-RB-CHB and lot number 8858425 on the device. The product was sold by Cook Inc. and is used in medical procedures.
Reach out to Cook Inc. directly to confirm if your device is affected and get instructions for next steps.
The sheaths are longer than specified, which could cause injury during use but is not a severe hazard. The risk is low and requires careful handling.
Check for the catalog number RCFW-5.0-25-45-RB-CHB and lot number 8858425 on the device. This specific model is affected.
Contact Cook Inc. directly to confirm if your device is affected and get instructions for next steps.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0851-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-0851-2019 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.
