Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide e...
FDA Device Recall #Z-1648-2016 — Class II — April 1, 2016
Recall Summary
| Recall Number | Z-1648-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 1, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 223 units |
Product Description
Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
Reason for Recall
Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
Distribution Pattern
Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
Lot / Code Information
Serial Numbers: AS1500000614 AS1500000615 AS1500000620 AS1500000621 AS1500000628 AS1500000630 AS1500000631 AS1500000633 AS1500000637 AS1500000638 AS1500000639 AS1500000640 AS1500000641 AS1500000643 AS1500000680 AS1500000681 AS1500000683 AS1500000685 AS1500000686 AS1500000687 AS1500000694 AS1500000695 AS1500000696 AS1500000697 AS1500000698 AS1500000699 AS1500000702 AS1500000703 AS1500000814 AS1500000820 AS1500000823 AS1500000824 AS1500000826 AS1500000827 AS1500000828 AS1500000830 AS1500000831 AS1500000833 AS1500000836 AS1500000837 AS1500000839 AS1500000842 AS1500000843 AS1500000845 AS1500000847 AS1500000849 AS1500000850 AS1500000852 AS1500000854 AS1500000856 AS1500000857 AS1500000858 AS1500000859 AS1500000860 AS1500000861 AS1500000862 AS1500000863 AS1500000866 AS1500000869 AS1500000872 AS1500000873 AS1500000874 AS1500000875 AS1500000876 AS1500000880 AS1500000883 AS1500000885 AS1500000887 AS1500000889 AS1500000891 AS1500000892 AS1500000894 AS1500000895 AS1500000896 AS1500000897 AS1500000898 AS1500000901 AS1500000902 AS1500000903 AS1500000904 AS1500000906 AS1500000907 AS1500000909 AS1500000911 AS1500000912 AS1500000913 AS1500000915 AS1500000916 AS1500000917 AS1500000921 AS1500000922 AS1500000923 AS1500000924 AS1500000925 AS1500000926 AS1500000927 AS1500000928 AS1500000929 AS1500000930 AS1500000932 AS1500000933 AS1500000934 AS1500000935 AS1500000936 AS1500000941 AS1500000942 AS1500000947 AS1500000948 AS1500000951 AS1500000952 AS1500000955 AS1500000970 AS1500000974 AS1500000975 AS1500000976 AS1500000977 AS1500000978 AS1500000979 AS1500000981 AS1500000996 AS1500000998 AS1500001002 AS1500001009 AS1500001044 AS1500001045 AS1500001058 AS1500001061 AS1500001069 AS1500001075 AS1500001084 AS1500001125 AS1500001134 AS1500001137 AS1500001145 AS1500001146 AS1500001148 AS1500001149 AS1500001151 AS1500001158 AS1500001163 AS1500001166 AS1500001171 AS1500001172 AS1500001175 AS1500001178 AS1500001180 AS1500001182 AS1500001188 AS1500001190 AS1500001191 AS1500001192 AS1500001199 AS1500001235 AS1500001236 AS1500001237 AS1500001240 AS1500001242 AS1500001243 AS1500001244 AS1500001245 AS1500001246 AS1500001247 AS1500001249 AS1500001250 AS1500001251 AS1500001252 AS1500001253 AS1500001256 AS1500001259 AS1500001260 AS1500001262 AS1500001263 AS1500001265 AS1500001267 AS1500001268 AS1500001269 AS1500001272 AS1500001273 AS1500001274 AS1500001275 AS1500001277 AS1500001279 AS1500001280 AS1500001281 AS1500001282 AS1500001283 AS1500001289 AS1500001292 AS1500001295 AS1500001296 AS1500001302 AS1500001303 AS1500001308 AS1500001309 AS1500001310 AS1500001312 AS1500001313 AS1500001317 AS1500001323 AS1500001324 AS1500001325 AS1500001326 AS1500001333 AS1500001334 AS1500001335 AS1500001336 AS1500001347 AS1500001370 AS1500001397 AS1500001403 AS1500001410 AS1500001421 AS1500001441 AS1500001450 AS1500001451 AS1500001455 AS1500001456 AS1500001466 AS1500001467 AS1500001472 AS1500001473 AS1500001474 AS1500001623
Other Recalls from Medtronic
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2548-2017 | Class II | SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 | May 3, 2017 |
| Z-2543-2017 | Class II | Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 4... | May 3, 2017 |
| Z-2547-2017 | Class II | CUSTOM SUTURE PACK; Item Number: US1540 and US1614 | May 3, 2017 |
| Z-2545-2017 | Class II | Best Practice Kit, Item Numbers: 00Z2064, 00Z21... | May 3, 2017 |
| Z-2544-2017 | Class II | Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 D... | May 3, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.