GA Health recalls ScopeValet Guardian Disposable Endoscope Valves Sets with sticky/broken suction buttons that may cause prolonged procedures. Affected units include 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 is recalling ScopeValet Guardian Disposable Endoscope Valves Sets because the suction button may become sticky or broken during procedures, leading to longer surgery times. This could delay critical medical treatments and increase patient risk.
The suction button in the valves may become sticky or broken during or after medical procedures. This can cause the procedure to take longer than intended, potentially delaying critical treatments and increasing patient risk.
Medical professionals using the ScopeValet Guardian Disposable Endoscope Valves Sets for procedures are most at risk. Patients undergoing surgery with these valves may experience longer procedures due to the suction button issue.
Check for product code 345SVVO1 and lot numbers 19122414, 20030401, or 20030402. The unit UDI is 0810929040380 and box UDI is 10810929040387.
Verify your ScopeValet Guardian Disposable Endoscope Valves Set has product code 345SVVO1 and lot numbers 19122414, 20030401, or 20030402.
The suction button may become sticky or broken during procedures, causing prolonged surgery times.
Check for product code 345SVVO1 and lot numbers 19122414, 20030401, or 20030402.
The recall does not specify a remedy, so contact GA Health directly for guidance.
We’ve drafted a message you can send GA Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0648-2021 — GA Health GA Health Hello, I own a GA Health that is covered by recall Z-0648-2021 from GA Health. 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.