Atrium Medical recalls 28French thoracic catheters due to sterile pouch expiring 5 days before case label. This mismatch risks infection from using expired sterile materials.
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date
Atrium Medical is recalling 28French thoracic catheters because the sterile pouch expires 5 days earlier than the case label. Using these catheters could lead to infections if the pouch is no longer sterile.
The sterile pouch expires 5 days earlier than the case label. Using the catheter after the pouch expires could allow bacteria to enter the chest cavity, causing infection.
Healthcare professionals using the catheters for chest drainage procedures. Patients receiving these catheters are at risk if the pouch expires before the case label.
Check the sterile pouch label for expiration date (16SEP2024) and the case label for expiration date (21SEP2024). The product has lot number ME231010 and UDI-DI 20650862150289.
Verify the sterile pouch expiration date (16SEP2024) and case label expiration date (21SEP2024).
The sterile pouch label shows expiration 16SEP2024 while the case and shipper labels show 21SEP2024, causing a 5-day mismatch.
The catheter is safe only until the pouch expires (16SEP2024). Using it after this date risks infection.
Check the expiration dates on the pouch and case labels. If the pouch expires earlier, contact Atrium Medical for guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1297-2022 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1297-2022 from Atrium Medical. 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.
