Cook recalls Pneumothorax Trays with Catalog No. C-UTPTY-1400-WAYNE-112497-IMH for potential sterility compromise in modified Wayne sets. Affected units may have lidstock perforation lines over sterile areas.
Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
Cook is recalling Pneumothorax Trays with specific catalog numbers due to a risk that the lidstock perforation line might be over the sterile area instead of the tray lip. This could compromise sterility during medical procedures, especially for modified Wayne sets used in pneumothorax treatment.
The lidstock perforation line on the tray may be positioned over the sterile area instead of the tray lip. This could lead to contamination of the sterile field during medical procedures, potentially causing infections.
Healthcare professionals using Cook's Pneumothorax Trays with the specified catalog number for modified Wayne sets. Patients undergoing pneumothorax treatment are at risk if the device is used incorrectly.
Check for Catalog No. C-UTPTY-1400-WAYNE-112497-IMH or GPN G56537 on the tray. The product is part of the modified Wayne Pneumothorax Set used for pneumothorax treatment.
Verify the catalog number and GPN code on the tray to confirm if it's affected.
The lidstock perforation line may be over the sterile area instead of the tray lip, potentially compromising sterility during medical procedures.
Check the catalog number and GPN code to confirm if it's affected; no specific action is required if it's not listed.
The product may have a sterility risk if the lidstock perforation line is over the sterile area instead of the tray lip.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0506-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0506-2020 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.
