Official recall notice

FDA DeviceClass IINotable

FDA Recall: OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS

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

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386

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