Cook Medical recalled 318 Wayne Pneumothorax Trays after labels showed expiration dates beyond true shelf life. The devices were distributed worldwide. Patients and healthcare providers should stop using these devices immediately and follow recall instructions from Cook Incorporated.
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 Tray is a medical device component used in thoracic procedures to manage pneumothorax-related steps within a clinical setting.
Expiration dates labeled beyond shelf life may compromise sterility or performance, risking patient safety during procedures.
This recall is not part of a broader industry pattern; it relates to mislabeling of expiration dates on specific lots.
Healthcare facilities must halt use of affected lots to avoid potential sterility issues and procedural delays.
FDA enforcement page linked in recall notice and Cook Incorporated's recall communications.
Refunds or replacements will follow Cook Incorporated procedures; expect weeks to months depending on inventory and provider.
Keep recall notices, inventory lists, UDI and lot number records, and all communications with Cook or healthcare facilities.
Products from the Wayne Pneumothorax Tray lots were distributed worldwide. Quantity: 318 units. Reference Part Numbers: C-UTPTY-1400-WAYNE-112497-IMH and C-UTPTY-1400-WAYNE-112497-IMH. UDI: 00827002565371(17)261020(10)15719344X; Lot Numbers: 15719344X, 15714808X, 15834145, 15834147. Recall date: 2026-03-05. Status: ACTIVE.
No specific injuries or incidents are reported in the provided data.
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