Coloplast Manufacturing US, LLC recalls
2 recalls on record · FDA
Every recall we have on record for Coloplast Manufacturing US, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
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Health Serious
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120,…
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Coloplast Manufacturing US, LLC Jan 22, 2025
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Health Serious
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Coloplast Manufacturing US, LLC Apr 19, 2023
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