KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS— 510(k) K141479
Substantially EquivalentCovidien
FDA 510(k) clearance K141479 for KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS, Substantially Equivalent on 2014-12-23. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code LZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Adverse events under product code LZH
product code LZH- Death
- 12
- Malfunction
- 4,186
- Total
- 4,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141479
K-number listed on FDA's recall record- Z-2100-2020 — Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
- Z-2101-2020 — Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
- Z-2105-2020 — Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141479.
Data sourced from openFDA. This site is unofficial and independent of the FDA.