Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal— 510(k) K153074
Substantially EquivalentCovidien
FDA 510(k) clearance K153074 for Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal, Substantially Equivalent on 2016-07-06. 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
Recent devices under product code LZH
view allMore clearances from Covidien
view all- K241486 — Sofsilk Coated Braided Silk Suture
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K231934 — GIA Stapler with Tri-Staple Technology
- K231240 — MaxTack Motorized Fixation Device
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
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 K153074
K-number listed on FDA's recall record- Z-0452-2021 — Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
- Z-0453-2021 — Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
- 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-2102-2020 — Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153074.
Data sourced from openFDA. This site is unofficial and independent of the FDA.