Cook Incorporated recalls 104 Wayne Pneumothorax Sets worldwide after labeling errors show expiration dates exceeding true shelf life. The recall affects reference parts C-UTPT-1020-WAYNE-IMH and C-UTPT-1400-WAYNE-112497-IMH with order numbers G56532 and G56535. Healthcare providers should stop use immediately and follow recall instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The Wayne Pneumothorax Set is a specialized medical device used by clinicians to manage pneumothorax during procedures. It is distributed globally to healthcare facilities.
Expiration dates printed on labels exceed the true shelf life, potentially affecting device performance or sterility.
This recall is not described as part of a broader industry pattern in the provided data.
Healthcare providers must verify lot numbers and expiration labeling to ensure patient safety. The recall could disrupt device availability and require stock checks.
Recall notices and device identifiers are typically in the FDA enforcement report and Cook Incorporated recall communications.
Refunds or replacements will be issued per Cook's recall instructions; timeline not specified in provided data.
Keep device lot numbers, expiration labels, purchase records, and all recall communications.
Recall date: 2026-03-05. Report date: 2026-04-15. Classification: Class II. Quantity: 104 units. Distribution: Worldwide. Reference Part Numbers: C-UTPT-1020-WAYNE-IMH (Order G56532); C-UTPT-1400-WAYNE-112497-IMH (Order G56535).
No injuries or incidents have been reported in the provided data.
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