FDA applicant

Infusyn Therapeutics, LLC

Hackettstown1 decision2012–201213 recalls

FDA records 1 decision for Infusyn Therapeutics, LLC (Hackettstown) in 2012: 1 original PMA approval. All are in product code LKK (Pump, Infusion, Implanted, Programmable). 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Infusyn Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2021

2012high 11 (2019) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Infusyn Therapeutics, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Infusyn Therapeutics, LLC

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?