Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets— 510(k) K143263
Substantially EquivalentCovidien
FDA 510(k) clearance K143263 for Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Substantially Equivalent on 2015-05-29. 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 K143263
K-number listed on FDA's recall record- Z-1648-2016 — Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
- Z-1649-2016 — Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143263.
Data sourced from openFDA. This site is unofficial and independent of the FDA.