Stryker Sustainability Solutions recalls Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6F, Large 4.0, 10…
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the hazard?
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
What's affected
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
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