Official recall notice

FDA DeviceClass IINotable

FDA Recall: CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidli

Recall date
2026-07-08
FDA class
Class II

Why it was recalled

Hazard

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Product description

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Affected products

CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 Lot Numbers: REKP2822 REKW2840 REKX3882 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 Lot Number: REKW2434 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 Lot Number: REKW0907 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 Lot Numbers: REKW2479 REKX3439 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 Lot Numbers: REKP0895 REKX0665 REKX2216 REKY1281

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