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FDA (Device enforcement)Recalled 2025-06-27class ii

Spiggle & Theis Mt Gmbh: Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 3

Hazard

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

Details from the source

Reason for recall: Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction. Distribution: US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio. Quantity: N/A Lot/code info: 1. Model No 50-353-23; UDI-DI 04250381858806; LOT (0)2241239 2. Model No 50-345-23; UDI-DI 04250381858813; LOT 2230438; LOT 2240251

UPC codes

04250381858806, 04250381858813

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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