BrosMed recalls Hermes NC PTA Balloon Dilatation Catheters with incorrect burst pressure ratings on labels. This may lead to device failure during medical procedures. Affected units include specific lot numbers listed in the recall notice.
Incorrect (higher) Rated Burst Pressure information printed on label.
BrosMed is recalling Hermes NC PTA Balloon Dilatation Catheters due to incorrect burst pressure ratings printed on labels. This could cause the catheter to fail during medical procedures, potentially leading to serious complications if used improperly.
The catheter has a higher burst pressure rating printed on the label than it actually can handle. If the catheter fails during medical procedures, it could cause injury to the patient or healthcare provider.
Healthcare professionals using the Hermes NC PTA Balloon Dilatation Catheter for medical procedures are likely affected. Patients receiving treatment with these catheters may be at risk if the device fails during use.
Check the lot numbers on the catheter: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
Look for the specific lot numbers listed in the recall notice: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
The catheter has a higher burst pressure rating printed on the label than it actually can handle, which could lead to device failure during medical procedures.
Lot numbers F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189 are affected.
The recall does not specify a need to stop using the catheters; the hazard is low risk and only affects specific lot numbers.
We’ve drafted a message you can send BrosMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2019 — BrosMed BrosMed Hello, I own a BrosMed that is covered by recall Z-0963-2019 from BrosMed. 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.
