Cook recalls Pressure Monitoring Set C-PMS G02838 with lot numbers 8910219-10148417 due to potential excess coating on needles that could cause blockage during use.
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Cook is recalling Pressure Monitoring Sets with specific lot numbers because excess coating on the needles might block blood flow. This could lead to inaccurate readings or complications during medical procedures.
The needles in the Pressure Monitoring Set may have excess coating that can block blood flow or cause inaccurate pressure readings. This could lead to incorrect medical decisions or complications during procedures.
Healthcare professionals using the Pressure Monitoring Set for medical procedures are most at risk. Patients receiving care with this device may also be affected if the coating causes blockages.
Check the lot number on the Pressure Monitoring Set label. The product is identified by the model C-PMS G02838 and lot numbers listed in the recall notice.
Look for the lot number on the Pressure Monitoring Set label to determine if it's affected.
The recalled device is the Pressure Monitoring Set, C-PMS, G02838.
Check the lot number on the device label; affected units have lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Cook Inc. for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-2203-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-2203-2020 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.