🔍 RecallPedia

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Class I - Dangerous
🏥 Medical Devices Recalled: June 16, 2022 Fresenius Medical Care Holdings Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)04251285200234(11)220308(21)2CHS5788 (01)04251285200234(11)220308(21)2CHS5790 (01)04251285200234(11)220308(21)2CHS5791 (01)04251285200234(11)220309(21)2CHS5793 (01)04251285200234(11)210628(21)1CHS5379 (01)04251285200234(11)181107(21)8CHS2658 (01)04251285200234(11)181113(21)8CHS2659 (01)04251285200234(11)181121(21)8CHS2672 (01)04251285200234(11)181126(21)8CHS2673 (01)04251285200234(11)181126(21)8CHS2678 (01)04251285200234(11)181121(21)8CHS2683 (01)04251285200234(11)181126(21)8CHS2653 (01)04251285200234(11)181018(21)8CHS2629 (01)04251285200234(11)181029(21)8CHS2637 (01)04251285200234(11)181121(21)8CHS2652 (01)04251285200234(11)181106(21)8CHS2655 (01)04251285200234(11)181113(21)8CHS2660 (01)04251285200234(11)181121(21)8CHS2662 (01)04251285200234(11)181108(21)8CHS2663 (01)04251285200234(11)181112(21)8CHS2668 (01)04251285200234(11)181116(21)8CHS2669 (01)04251285200234(11)181120(21)8CHS2677 (01)04251285200234(11)181116(21)8CHS2679 (01)04251285200234(11)181105(21)8CHS2597 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(01)04251285200234(11)181018(21)8CHS2626 (01)04251285200234(11)181029(21)8CHS2635 (01)04251285200234(11)181019(21)8CHS2612 (01)04251285200234(11)181002(21)8CHS2000 (01)04251285200234(11)180924(21)8CHS2537 (01)04251285200234(11)180927(21)8CHS2559 (01)04251285200234(11)180731(21)8CHS2413 (01)04251285200234(11)170807(21)7CHS1951 (01)04251285200234(11)170717(21)7CHS1935 (01)04251285200234(11)170608(21)7CHS1835 (01)04251285200234(11)170609(21)7CHS1845 (01)04251285200234(11)170613(21)7CHS1846 (01)04251285200234(11)170619(21)7CHS1852 (01)04251285200234(11)170619(21)7CHS1854 (01)04251285200234(11)170626(21)7CHS1859 (01)04251285200234(11)170530(21)7CHS1826 (01)04251285200234(11)170601(21)7CHS1830 (01)04251285200234(11)170531(21)7CHS1833 (01)04251285200234(11)170524(21)7CHS1808 (01)04251285200234(11)170519(21)7CHS1787 (01)04251285200234(11)170519(21)7CHS1789 (01)04251285200234(11)170522(21)7CHS1791 (01)04251285200234(11)170522(21)7CHS1792 (01)04251285200234(11)170524(21)7CHS1807 (01)04251285200234(11)170317(21)7CHS1666 (01)04251285200234(11)170427(21)7CHS1737 (01)04251285200234(11)170505(21)7CHS1760 (01)04251285200234(11)170309(21)7CHS1649 (01)04251285200234(11)170203(21)7CHS1589 (01)04251285200234(11)170203(21)7CHS1590 Serial Numbers: 2CHS5788 2CHS5790 2CHS5791 2CHS5793 1CHS5379 8CHS2658 8CHS2659 8CHS2672 8CHS2673 8CHS2678 8CHS2683 8CHS2653 8CHS2629 8CHS2637 8CHS2652 8CHS2655 8CHS2660 8CHS2662 8CHS2663 8CHS2668 8CHS2669 8CHS2677 8CHS2679 8CHS2597 8CHS2601 8CHS2642 8CHS2645 8CHS2646 8CHS2648 8CHS2649 8CHS2654 8CHS2657 8CHS2666 8CHS2667 8CHS2671 8CHS2644 8CHS2577 8CHS2578 8CHS2598 8CHS2614 8CHS2616 8CHS2619 8CHS2628 8CHS2631 8CHS2634 8CHS2636 8CHS2639 8CHS2650 8CHS2651 8CHS2633 8CHS2596 8CHS2599 8CHS2600 8CHS2605 8CHS2609 8CHS2613 8CHS2618 8CHS2620 8CHS2621 8CHS2623 8CHS2624 8CHS2625 8CHS2627 8CHS2608 8CHS2503 8CHS2541 8CHS2544 8CHS2561 8CHS2565 8CHS2566 8CHS2580 8CHS2581 8CHS2582 8CHS2604 8CHS2606 8CHS2607 8CHS2610 8CHS2611 8CHS2504 8CHS2527 8CHS2543 8CHS2560 8CHS2563 8CHS2564 8CHS2575 8CHS2538 8CHS2542 8CHS2562 8CHS2523 8CHS2526 8CHS2539 8CHS2540 8CHS2506 8CHS2508 8CHS2521 8CHS2522 8CHS2525 8CHS2528 8CHS2484 8CHS2485 8CHS2489 8CHS2501 8CHS2502 8CHS2505 8CHS2507 8CHS2409 8CHS2467 8CHS2469 8CHS2490 8CHS2464 8CHS2488 8CHS2449 8CHS2450 8CHS2465 8CHS2468 8CHS2470 8CHS2483 8CHS2445 8CHS2454 8CHS2463 8CHS2466 8CHS2303 8CHS2388 8CHS2447 8CHS2451 8CHS2452 8CHS2453 8CHS2414 8CHS2443 8CHS2444 8CHS2458 8CHS2393 8CHS2456 8CHS2387 8CHS2407 8CHS2411 8CHS2412 8CHS2415 8CHS2416 8CHS2417 8CHS2455 8CHS2457 8CHS2305 8CHS2306 8CHS2390 8CHS2406 8CHS2408 8CHS2410 8CHS2214 8CHS2304 8CHS2386 8CHS2389 8CHS2391 8CHS2392 8CHS2179 8CHS2200 8CHS2201 8CHS2202 8CHS2213 8CHS2215 8CHS2172 8CHS2173 8CHS2174 8CHS2178 8CHS2180 8CHS2181 8CHS2183 8CHS2198 8CHS2199 8CHS2177 8CHS2182 8CHS2197 8CHS2142 8CHS2144 8CHS2146 8CHS2147 8CHS2148 8CHS2149 8CHS2150 8CHS2151 8CHS2152 8CHS2153 8CHS2175 8CHS2176 8CHS2127 8CHS2128 8CHS2131 8CHS2132 8CHS2136 8CHS2137 8CHS2138 8CHS2139 8CHS2140 8CHS2141 8CHS2143 8CHS2145 8CHS2112 8CHS2113 8CHS2114 8CHS2115 8CHS2116 8CHS2117 8CHS2118 8CHS2119 8CHS2120 8CHS2130 7CHS1952 7CHS1953 7CHS1922 7CHS1936 7CHS1941 7CHS1923 7CHS1925 7CHS1937 7CHS1939 7CHS1940 7CHS1906 7CHS1913 7CHS1934 7CHS1892 7CHS1915 7CHS1874 7CHS1847 7CHS1849 7CHS1850 7CHS1851 7CHS1856 7CHS1853 7CHS1860 7CHS1834 7CHS1762 7CHS1805 7CHS1756 7CHS1763 7CHS1765 7CHS1776 7CHS1766 7CHS1790 7CHS1764 7CHS1759 7CHS1761 7CHS1641 7CHS1619 7CHS1569 7CHS1583 6CHS1394 6CHS1396 6CHS1435 6CHS1270 6CHS1196 2CHS5789 2CHS5792 1CHS5056 0CHS4484 0CHS4385 0CHS4386 0CHS4387 0CHS4397 0CHS4398 0CHS4399 0CHS4400 0CHS4401 0CHS4402 0CHS4273 0CHS4290 0CHS4291 0CHS4292 0CHS4293 0CHS4294 0CHS4295 0CHS4296 0CHS4297 0CHS4298 0CHS4347 0CHS4348 0CHS4349 0CHS4350 0CHS4237 0CHS4238 0CHS4239 0CHS4240 0CHS4268 0CHS4269 0CHS4270 0CHS4271 0CHS4272 0CHS4289 8CHS2675 8CHS2626 8CHS2635 8CHS2612 8CHS2000 8CHS2537 8CHS2559 8CHS2413 7CHS1951 7CHS1935 7CHS1835 7CHS1845 7CHS1846 7CHS1852 7CHS1854 7CHS1859 7CHS1826 7CHS1830 7CHS1833 7CHS1808 7CHS1787 7CHS1789 7CHS1791 7CHS1792 7CHS1807 7CHS1666 7CHS1737 7CHS1760 7CHS1649 7CHS1589 7CHS1590
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Fresenius Medical Care Holdings, Inc.
Reason for Recall:
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Product Codes/Lot Numbers:

UDI-DI: (01)04251285200234(11)220308(21)2CHS5788 (01)04251285200234(11)220308(21)2CHS5790 (01)04251285200234(11)220308(21)2CHS5791 (01)04251285200234(11)220309(21)2CHS5793 (01)04251285200234(11)210628(21)1CHS5379 (01)04251285200234(11)181107(21)8CHS2658 (01)04251285200234(11)181113(21)8CHS2659 (01)04251285200234(11)181121(21)8CHS2672 (01)04251285200234(11)181126(21)8CHS2673 (01)04251285200234(11)181126(21)8CHS2678 (01)04251285200234(11)181121(21)8CHS2683 (01)04251285200234(11)181126(21)8CHS2653 (01)04251285200234(11)181018(21)8CHS2629 (01)04251285200234(11)181029(21)8CHS2637 (01)04251285200234(11)181121(21)8CHS2652 (01)04251285200234(11)181106(21)8CHS2655 (01)04251285200234(11)181113(21)8CHS2660 (01)04251285200234(11)181121(21)8CHS2662 (01)04251285200234(11)181108(21)8CHS2663 (01)04251285200234(11)181112(21)8CHS2668 (01)04251285200234(11)181116(21)8CHS2669 (01)04251285200234(11)181120(21)8CHS2677 (01)04251285200234(11)181116(21)8CHS2679 (01)04251285200234(11)181105(21)8CHS2597 (01)04251285200234(11)181108(21)8CHS2601 (01)04251285200234(11)181102(21)8CHS2642 (01)04251285200234(11)181107(21)8CHS2645 (01)04251285200234(11)181108(21)8CHS2646 (01)04251285200234(11)181108(21)8CHS2648 (01)04251285200234(11)181109(21)8CHS2649 (01)04251285200234(11)181107(21)8CHS2654 (01)04251285200234(11)181107(21)8CHS2657 (01)04251285200234(11)181113(21)8CHS2666 (01)04251285200234(11)181112(21)8CHS2667 (01)04251285200234(11)181113(21)8CHS2671 (01)04251285200234(11)181107(21)8CHS2644 (01)04251285200234(11)181009(21)8CHS2577 (01)04251285200234(11)181009(21)8CHS2578 (01)04251285200234(11)181015(21)8CHS2598 (01)04251285200234(11)181025(21)8CHS2614 (01)04251285200234(11)181025(21)8CHS2616 (01)04251285200234(11)181025(21)8CHS2619 (01)04251285200234(11)181017(21)8CHS2628 (01)04251285200234(11)181023(21)8CHS2631 (01)04251285200234(11)181031(21)8CHS2634 (01)04251285200234(11)181029(21)8CHS2636 (01)04251285200234(11)181029(21)8CHS2639 (01)04251285200234(11)181106(21)8CHS2650 (01)04251285200234(11)181102(21)8CHS2651 (01)04251285200234(11)181102(21)8CHS2633 (01)04251285200234(11)181015(21)8CHS2596 (01)04251285200234(11)181017(21)8CHS2599 (01)04251285200234(11)181022(21)8CHS2600 (01)04251285200234(11)181008(21)8CHS2605 (01)04251285200234(11)181010(21)8CHS2609 (01)04251285200234(11)181022(21)8CHS2613 (01)04251285200234(11)181029(21)8CHS2618 (01)04251285200234(11)181022(21)8CHS2620 (01)04251285200234(11)181018(21)8CHS2621 (01)04251285200234(11)181017(21)8CHS2623 (01)04251285200234(11)181017(21)8CHS2624 (01)04251285200234(11)181019(21)8CHS2625 (01)04251285200234(11)181017(21)8CHS2627 (01)04251285200234(11)181010(21)8CHS2608 (01)04251285200234(11)180919(21)8CHS2503 (01)04251285200234(11)180926(21)8CHS2541 (01)04251285200234(11)180926(21)8CHS2544 (01)04251285200234(11)180928(21)8CHS2561 (01)04251285200234(11)181001(21)8CHS2565 (01)04251285200234(11)181009(21)8CHS2566 (01)04251285200234(11)181004(21)8CHS2580 (01)04251285200234(11)181010(21)8CHS2581 (01)04251285200234(11)181008(21)8CHS2582 (01)04251285200234(11)181005(21)8CHS2604 (01)04251285200234(11)181004(21)8CHS2606 (01)04251285200234(11)181011(21)8CHS2607 (01)04251285200234(11)181008(21)8CHS2610 (01)04251285200234(11)181010(21)8CHS2611 (01)04251285200234(11)180920(21)8CHS2504 (01)04251285200234(11)180924(21)8CHS2527 (01)04251285200234(11)180926(21)8CHS2543 (01)04251285200234(11)180926(21)8CHS2560 (01)04251285200234(11)180926(21)8CHS2563 (01)04251285200234(11)180926(21)8CHS2564 (01)04251285200234(11)181002(21)8CHS2575 (01)04251285200234(11)180924(21)8CHS2538 (01)04251285200234(11)180926(21)8CHS2542 (01)04251285200234(11)180927(21)8CHS2562 (01)04251285200234(11)180919(21)8CHS2523 (01)04251285200234(11)180919(21)8CHS2526 (01)04251285200234(11)180919(21)8CHS2539 (01)04251285200234(11)180920(21)8CHS2540 (01)04251285200234(11)180914(21)8CHS2506 (01)04251285200234(11)180914(21)8CHS2508 (01)04251285200234(11)180918(21)8CHS2521 (01)04251285200234(11)180918(21)8CHS2522 (01)04251285200234(11)180913(21)8CHS2525 (01)04251285200234(11)180914(21)8CHS2528 (01)04251285200234(11)180911(21)8CHS2484 (01)04251285200234(11)180912(21)8CHS2485 (01)04251285200234(11)180913(21)8CHS2489 (01)04251285200234(11)180912(21)8CHS2501 (01)04251285200234(11)180910(21)8CHS2502 (01)04251285200234(11)180910(21)8CHS2505 (01)04251285200234(11)180911(21)8CHS2507 (01)04251285200234(11)180830(21)8CHS2409 (01)04251285200234(11)180904(21)8CHS2467 (01)04251285200234(11)180904(21)8CHS2469 (01)04251285200234(11)180905(21)8CHS2490 (01)04251285200234(11)180830(21)8CHS2464 (01)04251285200234(11)180831(21)8CHS2488 (01)04251285200234(11)180821(21)8CHS2449 (01)04251285200234(11)180830(21)8CHS2450 (01)04251285200234(11)180829(21)8CHS2465 (01)04251285200234(11)180828(21)8CHS2468 (01)04251285200234(11)180830(21)8CHS2470 (01)04251285200234(11)180829(21)8CHS2483 (01)04251285200234(11)180821(21)8CHS2445 (01)04251285200234(11)180821(21)8CHS2454 (01)04251285200234(11)180823(21)8CHS2463 (01)04251285200234(11)180823(21)8CHS2466 (01)04251285200234(11)180816(21)8CHS2303 (01)04251285200234(11)180814(21)8CHS2388 (01)04251285200234(11)180816(21)8CHS2447 (01)04251285200234(11)180814(21)8CHS2451 (01)04251285200234(11)180814(21)8CHS2452 (01)04251285200234(11)180809(21)8CHS2453 (01)04251285200234(11)180807(21)8CHS2414 (01)04251285200234(11)180807(21)8CHS2443 (01)04251285200234(11)180809(21)8CHS2444 (01)04251285200234(11)180807(21)8CHS2458 (01)04251285200234(11)180802(21)8CHS2393 (01)04251285200234(11)180806(21)8CHS2456 (01)04251285200234(11)180803(21)8CHS2387 (01)04251285200234(11)180728(21)8CHS2407 (01)04251285200234(11)180801(21)8CHS2411 (01)04251285200234(11)180801(21)8CHS2412 (01)04251285200234(11)180731(21)8CHS2415 (01)04251285200234(11)180731(21)8CHS2416 (01)04251285200234(11)180731(21)8CHS2417 (01)04251285200234(11)180802(21)8CHS2455 (01)04251285200234(11)180803(21)8CHS2457 (01)04251285200234(11)180723(21)8CHS2305 (01)04251285200234(11)180725(21)8CHS2306 (01)04251285200234(11)180724(21)8CHS2390 (01)04251285200234(11)180725(21)8CHS2406 (01)04251285200234(11)180725(21)8CHS2408 (01)04251285200234(11)180726(21)8CHS2410 (01)04251285200234(11)180404(21)8CHS2214 (01)04251285200234(11)180716(21)8CHS2304 (01)04251285200234(11)180719(21)8CHS2386 (01)04251285200234(11)180724(21)8CHS2389 (01)04251285200234(11)180723(21)8CHS2391 (01)04251285200234(11)180716(21)8CHS2392 (01)04251285200234(11)180313(21)8CHS2179 (01)04251285200234(11)180403(21)8CHS2200 (01)04251285200234(11)180403(21)8CHS2201 (01)04251285200234(11)180404(21)8CHS2202 (01)04251285200234(11)180404(21)8CHS2213 (01)04251285200234(11)180405(21)8CHS2215 (01)04251285200234(11)180307(21)8CHS2172 (01)04251285200234(11)180307(21)8CHS2173 (01)04251285200234(11)180307(21)8CHS2174 (01)04251285200234(11)180313(21)8CHS2178 (01)04251285200234(11)180314(21)8CHS2180 (01)04251285200234(11)180315(21)8CHS2181 (01)04251285200234(11)180316(21)8CHS2183 (01)04251285200234(11)180327(21)8CHS2198 (01)04251285200234(11)180327(21)8CHS2199 (01)04251285200234(11)180309(21)8CHS2177 (01)04251285200234(11)180315(21)8CHS2182 (01)04251285200234(11)180326(21)8CHS2197 (01)04251285200234(11)180220(21)8CHS2142 (01)04251285200234(11)180226(21)8CHS2144 (01)04251285200234(11)180227(21)8CHS2146 (01)04251285200234(11)180227(21)8CHS2147 (01)04251285200234(11)180228(21)8CHS2148 (01)04251285200234(11)180301(21)8CHS2149 (01)04251285200234(11)180301(21)8CHS2150 (01)04251285200234(11)180301(21)8CHS2151 (01)04251285200234(11)180302(21)8CHS2152 (01)04251285200234(11)180302(21)8CHS2153 (01)04251285200234(11)180309(21)8CHS2175 (01)04251285200234(11)180309(21)8CHS2176 (01)04251285200234(11)180208(21)8CHS2127 (01)04251285200234(11)180208(21)8CHS2128 (01)04251285200234(11)180213(21)8CHS2131 (01)04251285200234(11)180213(21)8CHS2132 (01)04251285200234(11)180219(21)8CHS2136 (01)04251285200234(11)180220(21)8CHS2137 (01)04251285200234(11)180220(21)8CHS2138 (01)04251285200234(11)180220(21)8CHS2139 (01)04251285200234(11)180220(21)8CHS2140 (01)04251285200234(11)180221(21)8CHS2141 (01)04251285200234(11)180220(21)8CHS2143 (01)04251285200234(11)180226(21)8CHS2145 (01)04251285200234(11)180205(21)8CHS2112 (01)04251285200234(11)180205(21)8CHS2113 (01)04251285200234(11)180205(21)8CHS2114 (01)04251285200234(11)180205(21)8CHS2115 (01)04251285200234(11)180205(21)8CHS2116 (01)04251285200234(11)180206(21)8CHS2117 (01)04251285200234(11)180206(21)8CHS2118 (01)04251285200234(11)180206(21)8CHS2119 (01)04251285200234(11)180206(21)8CHS2120 (01)04251285200234(11)180209(21)8CHS2130 (01)04251285200234(11)170807(21)7CHS1952 (01)04251285200234(11)170807(21)7CHS1953 (01)04251285200234(11)170731(21)7CHS1922 (01)04251285200234(11)170717(21)7CHS1936 (01)04251285200234(11)170719(21)7CHS1941 (01)04251285200234(11)170724(21)7CHS1923 (01)04251285200234(11)170801(21)7CHS1925 (01)04251285200234(11)170717(21)7CHS1937 (01)04251285200234(11)170718(21)7CHS1939 (01)04251285200234(11)170719(21)7CHS1940 (01)04251285200234(11)170705(21)7CHS1906 (01)04251285200234(11)170712(21)7CHS1913 (01)04251285200234(11)170724(21)7CHS1934 (01)04251285200234(11)170703(21)7CHS1892 (01)04251285200234(11)170713(21)7CHS1915 (01)04251285200234(11)170627(21)7CHS1874 (01)04251285200234(11)170609(21)7CHS1847 (01)04251285200234(11)170612(21)7CHS1849 (01)04251285200234(11)170613(21)7CHS1850 (01)04251285200234(11)170614(21)7CHS1851 (01)04251285200234(11)170626(21)7CHS1856 (01)04251285200234(11)170614(21)7CHS1853 (01)04251285200234(11)170621(21)7CHS1860 (01)04251285200234(11)170608(21)7CHS1834 (01)04251285200234(11)170505(21)7CHS1762 (01)04251285200234(11)170524(21)7CHS1805 (01)04251285200234(11)170502(21)7CHS1756 (01)04251285200234(11)170508(21)7CHS1763 (01)04251285200234(11)170512(21)7CHS1765 (01)04251285200234(11)170512(21)7CHS1776 (01)04251285200234(11)170515(21)7CHS1766 (01)04251285200234(11)170519(21)7CHS1790 (01)04251285200234(11)170508(21)7CHS1764 (01)04251285200234(11)170509(21)7CHS1759 (01)04251285200234(11)170505(21)7CHS1761 (01)04251285200234(11)170314(21)7CHS1641 (01)04251285200234(11)170213(21)7CHS1619 (01)04251285200234(11)170131(21)7CHS1569 (01)04251285200234(11)170201(21)7CHS1583 (01)04251285200234(11)161109(21)6CHS1394 (01)04251285200234(11)161108(21)6CHS1396 (01)04251285200234(11)161109(21)6CHS1435 (01)04251285200234(11)160927(21)6CHS1270 (01)04251285200234(11)161109(21)6CHS1196 (01)04251285200234(11)220308(21)2CHS5789 (01)04251285200234(11)220308(21)2CHS5792 (01)04251285200234(11)210211(21)1CHS5056 (01)04251285200234(11)200716(21)0CHS4484 (01)04251285200234(11)200706(21)0CHS4385 (01)04251285200234(11)200706(21)0CHS4386 (01)04251285200234(11)200706(21)0CHS4387 (01)04251285200234(11)200706(21)0CHS4397 (01)04251285200234(11)200706(21)0CHS4398 (01)04251285200234(11)200706(21)0CHS4399 (01)04251285200234(11)200706(21)0CHS4400 (01)04251285200234(11)200707(21)0CHS4401 (01)04251285200234(11)200706(21)0CHS4402 (01)04251285200234(11)200622(21)0CHS4273 (01)04251285200234(11)200624(21)0CHS4290 (01)04251285200234(11)200624(21)0CHS4291 (01)04251285200234(11)200625(21)0CHS4292 (01)04251285200234(11)200625(21)0CHS4293 (01)04251285200234(11)200625(21)0CHS4294 (01)04251285200234(11)200625(21)0CHS4295 (01)04251285200234(11)200625(21)0CHS4296 (01)04251285200234(11)200629(21)0CHS4297 (01)04251285200234(11)200630(21)0CHS4298 (01)04251285200234(11)200630(21)0CHS4347 (01)04251285200234(11)200630(21)0CHS4348 (01)04251285200234(11)200630(21)0CHS4349 (01)04251285200234(11)200630(21)0CHS4350 (01)04251285200234(11)200618(21)0CHS4237 (01)04251285200234(11)200617(21)0CHS4238 (01)04251285200234(11)200622(21)0CHS4239 (01)04251285200234(11)200622(21)0CHS4240 (01)04251285200234(11)200623(21)0CHS4268 (01)04251285200234(11)200623(21)0CHS4269 (01)04251285200234(11)200623(21)0CHS4270 (01)04251285200234(11)200623(21)0CHS4271 (01)04251285200234(11)200624(21)0CHS4272 (01)04251285200234(11)200624(21)0CHS4289 (01)04251285200234(11)181120(21)8CHS2675 (01)04251285200234(11)181018(21)8CHS2626 (01)04251285200234(11)181029(21)8CHS2635 (01)04251285200234(11)181019(21)8CHS2612 (01)04251285200234(11)181002(21)8CHS2000 (01)04251285200234(11)180924(21)8CHS2537 (01)04251285200234(11)180927(21)8CHS2559 (01)04251285200234(11)180731(21)8CHS2413 (01)04251285200234(11)170807(21)7CHS1951 (01)04251285200234(11)170717(21)7CHS1935 (01)04251285200234(11)170608(21)7CHS1835 (01)04251285200234(11)170609(21)7CHS1845 (01)04251285200234(11)170613(21)7CHS1846 (01)04251285200234(11)170619(21)7CHS1852 (01)04251285200234(11)170619(21)7CHS1854 (01)04251285200234(11)170626(21)7CHS1859 (01)04251285200234(11)170530(21)7CHS1826 (01)04251285200234(11)170601(21)7CHS1830 (01)04251285200234(11)170531(21)7CHS1833 (01)04251285200234(11)170524(21)7CHS1808 (01)04251285200234(11)170519(21)7CHS1787 (01)04251285200234(11)170519(21)7CHS1789 (01)04251285200234(11)170522(21)7CHS1791 (01)04251285200234(11)170522(21)7CHS1792 (01)04251285200234(11)170524(21)7CHS1807 (01)04251285200234(11)170317(21)7CHS1666 (01)04251285200234(11)170427(21)7CHS1737 (01)04251285200234(11)170505(21)7CHS1760 (01)04251285200234(11)170309(21)7CHS1649 (01)04251285200234(11)170203(21)7CHS1589 (01)04251285200234(11)170203(21)7CHS1590 Serial Numbers: 2CHS5788 2CHS5790 2CHS5791 2CHS5793 1CHS5379 8CHS2658 8CHS2659 8CHS2672 8CHS2673 8CHS2678 8CHS2683 8CHS2653 8CHS2629 8CHS2637 8CHS2652 8CHS2655 8CHS2660 8CHS2662 8CHS2663 8CHS2668 8CHS2669 8CHS2677 8CHS2679 8CHS2597 8CHS2601 8CHS2642 8CHS2645 8CHS2646 8CHS2648 8CHS2649 8CHS2654 8CHS2657 8CHS2666 8CHS2667 8CHS2671 8CHS2644 8CHS2577 8CHS2578 8CHS2598 8CHS2614 8CHS2616 8CHS2619 8CHS2628 8CHS2631 8CHS2634 8CHS2636 8CHS2639 8CHS2650 8CHS2651 8CHS2633 8CHS2596 8CHS2599 8CHS2600 8CHS2605 8CHS2609 8CHS2613 8CHS2618 8CHS2620 8CHS2621 8CHS2623 8CHS2624 8CHS2625 8CHS2627 8CHS2608 8CHS2503 8CHS2541 8CHS2544 8CHS2561 8CHS2565 8CHS2566 8CHS2580 8CHS2581 8CHS2582 8CHS2604 8CHS2606 8CHS2607 8CHS2610 8CHS2611 8CHS2504 8CHS2527 8CHS2543 8CHS2560 8CHS2563 8CHS2564 8CHS2575 8CHS2538 8CHS2542 8CHS2562 8CHS2523 8CHS2526 8CHS2539 8CHS2540 8CHS2506 8CHS2508 8CHS2521 8CHS2522 8CHS2525 8CHS2528 8CHS2484 8CHS2485 8CHS2489 8CHS2501 8CHS2502 8CHS2505 8CHS2507 8CHS2409 8CHS2467 8CHS2469 8CHS2490 8CHS2464 8CHS2488 8CHS2449 8CHS2450 8CHS2465 8CHS2468 8CHS2470 8CHS2483 8CHS2445 8CHS2454 8CHS2463 8CHS2466 8CHS2303 8CHS2388 8CHS2447 8CHS2451 8CHS2452 8CHS2453 8CHS2414 8CHS2443 8CHS2444 8CHS2458 8CHS2393 8CHS2456 8CHS2387 8CHS2407 8CHS2411 8CHS2412 8CHS2415 8CHS2416 8CHS2417 8CHS2455 8CHS2457 8CHS2305 8CHS2306 8CHS2390 8CHS2406 8CHS2408 8CHS2410 8CHS2214 8CHS2304 8CHS2386 8CHS2389 8CHS2391 8CHS2392 8CHS2179 8CHS2200 8CHS2201 8CHS2202 8CHS2213 8CHS2215 8CHS2172 8CHS2173 8CHS2174 8CHS2178 8CHS2180 8CHS2181 8CHS2183 8CHS2198 8CHS2199 8CHS2177 8CHS2182 8CHS2197 8CHS2142 8CHS2144 8CHS2146 8CHS2147 8CHS2148 8CHS2149 8CHS2150 8CHS2151 8CHS2152 8CHS2153 8CHS2175 8CHS2176 8CHS2127 8CHS2128 8CHS2131 8CHS2132 8CHS2136 8CHS2137 8CHS2138 8CHS2139 8CHS2140 8CHS2141 8CHS2143 8CHS2145 8CHS2112 8CHS2113 8CHS2114 8CHS2115 8CHS2116 8CHS2117 8CHS2118 8CHS2119 8CHS2120 8CHS2130 7CHS1952 7CHS1953 7CHS1922 7CHS1936 7CHS1941 7CHS1923 7CHS1925 7CHS1937 7CHS1939 7CHS1940 7CHS1906 7CHS1913 7CHS1934 7CHS1892 7CHS1915 7CHS1874 7CHS1847 7CHS1849 7CHS1850 7CHS1851 7CHS1856 7CHS1853 7CHS1860 7CHS1834 7CHS1762 7CHS1805 7CHS1756 7CHS1763 7CHS1765 7CHS1776 7CHS1766 7CHS1790 7CHS1764 7CHS1759 7CHS1761 7CHS1641 7CHS1619 7CHS1569 7CHS1583 6CHS1394 6CHS1396 6CHS1435 6CHS1270 6CHS1196 2CHS5789 2CHS5792 1CHS5056 0CHS4484 0CHS4385 0CHS4386 0CHS4387 0CHS4397 0CHS4398 0CHS4399 0CHS4400 0CHS4401 0CHS4402 0CHS4273 0CHS4290 0CHS4291 0CHS4292 0CHS4293 0CHS4294 0CHS4295 0CHS4296 0CHS4297 0CHS4298 0CHS4347 0CHS4348 0CHS4349 0CHS4350 0CHS4237 0CHS4238 0CHS4239 0CHS4240 0CHS4268 0CHS4269 0CHS4270 0CHS4271 0CHS4272 0CHS4289 8CHS2675 8CHS2626 8CHS2635 8CHS2612 8CHS2000 8CHS2537 8CHS2559 8CHS2413 7CHS1951 7CHS1935 7CHS1835 7CHS1845 7CHS1846 7CHS1852 7CHS1854 7CHS1859 7CHS1826 7CHS1830 7CHS1833 7CHS1808 7CHS1787 7CHS1789 7CHS1791 7CHS1792 7CHS1807 7CHS1666 7CHS1737 7CHS1760 7CHS1649 7CHS1589 7CHS1590

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1464-2022

Related Recalls

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

Fresenius Medical Care Holdings

Class I - Dangerous

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

Aug 29, 2025 Other Medical Devices Nationwide View Details →

5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

Fresenius Medical Care Holdings

Class I - Dangerous

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

Apr 29, 2025 Other Medical Devices Nationwide View Details →