FDAHealthJune 27, 2025
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 l
⚠️ Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 27, 2025
US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
What's affected?
- Product
- 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 31 cm, non-sterile
- Lot code
- (0)2241239
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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