KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS— 510(k) K040196
Substantially EquivalentTyco Healthcare/Kendall
FDA 510(k) clearance K040196 for KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS, Substantially Equivalent on 2004-05-05. Applicant: Tyco Healthcare/Kendall. Device class: 2.
Clearance details
- Applicant
- Tyco Healthcare/Kendall
- 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
Recent devices under product code LZH
view allMore clearances from Tyco Healthcare/Kendall
view allAdverse 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 K040196
K-number listed on FDA's recall record- Z-1347-2021 — Enteral Infusion Pump
- 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-2103-2020 — Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
- Z-2104-2020 — Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040196.
Data sourced from openFDA. This site is unofficial and independent of the FDA.