Intersurgical recalls Smoothbore breathing systems with incorrect 22mm exhalation port (model B0062001) due to gas leakage risk during anesthesia. Affected units include lot numbers 4200283 and 4200286.
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Intersurgical is recalling a specific model of anesthesia breathing system because it was assembled with the wrong exhalation port, which can cause gas leakage. This could lead to unsafe medical gas levels for patients during anesthesia procedures.
The device has an incorrect 22mm exhalation port that can cause gas leakage during anesthesia procedures. This may lead to unsafe gas levels for patients if the system is used without proper adjustment.
Healthcare professionals using the Smoothbore breathing system with model number B0062001 and lot numbers 4200283 or 4200286 are most at risk. Patients receiving anesthesia with this device may experience gas leakage.
Check for model number B0062001 and lot numbers 4200283 or 4200286 on the device. The product was sold as a Custom Anasthesia Breathing System for medical use.
Verify the model number and lot numbers on the device to confirm if it is affected.
The model number is B0062001.
Lot numbers 4200283 and 4200286 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Intersurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0753-2021 — Intersurgical Intersurgical Hello, I own a Intersurgical that is covered by recall Z-0753-2021 from Intersurgical. 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.