human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Summary
The FDA issued a Class II for human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF by HUMAN MED AG. Reason: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet.
Details
Source
Device Recall
External ID
Z-1251-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Lot/Code Info: Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.
Quantity Affected: 775 devices
Reason for Recall
The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
Distribution
US Nationwide distribution in the state of FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-18
Company
Schwerin
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 132 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 (HUMAN MED AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HUMAN MED AG have FDA actions?
This is the only FDA action we have on record for HUMAN MED AG in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1251-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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