Official recall notice

FDA DeviceClass INotable

FDA Recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A

Recall date
2026-07-22
FDA class
Class I

Why it was recalled

Hazard

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Product description

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Affected products

REF/UDI-DI Box:Unit/Lot(Expiration): 008416A/20886333217636:00886333217632/11656898(7/19/2027); 008566A/20886333217643:00886333217649/11654475(12/31/2026), 11654478(7/19/2027)

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