GA Health Company recalls STOPCON Disposable Valves due to sticky/broken suction button causing prolonged procedures. Affected units have specific product codes and lot numbers.
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
GA Health Company is recalling STOPCON Disposable Valves because the suction button may become sticky or broken during procedures, leading to longer surgery times. This could cause unnecessary delays and complications for patients.
The suction button can become sticky or broken during or after procedures, which may cause the procedure to take longer than intended. This could lead to increased patient discomfort and potential complications.
Surgical staff and patients using the STOPCON Disposable Valves for procedures like air-water or biopsy. Those with specific product codes and lot numbers are most at risk.
Check for product code EN10229 and lot numbers 19121831 or 20032007. The unit UDI is 04897106951093 and box UDI is 14897106951090.
Look for product code EN10229 and lot numbers 19121831 or 20032007 on the packaging.
The suction button may become sticky or broken during or after procedures, causing the procedure to take longer than intended.
Check for product code EN10229 and lot numbers 19121831 or 20032007. If you have these, contact GA Health Company for instructions.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send GA Health Company to request your refund or repair — edit it as you like.
Subject: Recall Z-0639-2021 — GA Health Company GA Health Company Hello, I own a GA Health Company that is covered by recall Z-0639-2021 from GA Health Company. 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.
