Cook recalls specific vinyl connecting tubes due to potential packaging seal breach, risking sterility compromise. Affected lots have unique part numbers and expiration dates.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Cook is recalling certain vinyl connecting tubes that may have a broken packaging seal, which could compromise their sterility. This means the tubes might not be safe for medical use if they were used in procedures requiring sterile equipment.
The packaging seal may be completely breached, leading to potential contamination of the tubes. This could compromise sterility, especially if the tubes are used in medical procedures where sterility is critical.
Healthcare professionals using these tubes in medical procedures are most at risk. Patients receiving procedures with compromised sterile equipment could face infection risks.
Check for part numbers CTU14.0-30-ST, CTU14.0-40-ST, CTU14.0-30, CTU14.0-50-ST, or C-CTU14.0-30-ST with specific lot numbers and expiration dates listed in the recall notice.
Look for the part numbers and lot numbers listed in the recall notice to determine if your tube is affected.
Cook identified that some devices may have a complete breach of the chevron seal in the packaging, which could compromise sterility.
Affected part numbers include CTU14.0-30-ST, CTU14.0-40-ST, CTU14.0-30, CTU14.0-50-ST, and C-CTU14.0-30-ST with specific lot numbers and expiration dates listed in the recall notice.
Check the product label for the part numbers and lot numbers listed in the recall notice to see if they match the affected items.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1844-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1844-2022 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.