Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913L) due to potential sterile barrier breach. Affected units may require replacement to prevent infection risks during medical procedures.
Certain lots of product have the potential for a sterile barrier breach.
Medtronic is recalling certain lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913L) because they might have a sterile barrier breach. This could lead to infections during medical procedures if the device is used improperly.
The sterile barrier breach could allow contaminants to enter the device, increasing infection risk during critical medical procedures like cardiopulmonary bypass. This is a potential issue for devices used in surgical settings where sterility is essential.
Healthcare professionals using the device for cardiopulmonary bypass procedures are most at risk. Patients receiving these procedures may be affected if the device is used on the wrong lot numbers.
Check for the model number 94913L on the device. Look for lot numbers 0231665646 or 0231665648 on the packaging or label. The product was sold with GTIN 00643169454460 or 20643169454464.
Look for lot numbers 0231665646 or 0231665648 on the device packaging or label.
The recalled device is Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L.
Lot numbers 0231665646 and 0231665648 are affected.
Check for the model number 94913L and lot numbers 0231665646 or 0231665648 on the packaging or label.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2220-2026 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2220-2026 from Medtronic Perfusion Systems. 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.
