Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;
Summary
The FDA issued a Class II for Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length by Spiggle & Theis Mt Gmbh. Reason: Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction..
Details
Source
Device Recall
External ID
Z-2331-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
Product Description
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 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
Quantity Affected: N/A
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-27
Company
Dieburg, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spiggle & Theis Mt Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spiggle & Theis Mt Gmbh have FDA actions?
This is the only FDA action we have on record for Spiggle & Theis Mt Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2331-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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