| Date Initiated by Firm | June 16, 2022 |
|---|
| Date Posted | July 25, 2022 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1464-2022 |
|---|
| Recall Event ID |
90527 |
| 510(K)Number | K143617 |
|---|
| Product Classification |
Subsystem, water purification - Product Code FIP
|
| Product | AquaC UNO H [120V, 60Hz, 1000VA,
Fresenius US-Version: 24-10VA-1
Vivonic Part Number: G02000970-US |
|---|
| Code Information |
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
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(01)04251285200234(11)170807(21)7CHS1952
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(01)04251285200234(11)170717(21)7CHS1936
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(01)04251285200234(11)170801(21)7CHS1925
(01)04251285200234(11)170717(21)7CHS1937
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(01)04251285200234(11)170719(21)7CHS1940
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(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
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(01)04251285200234(11)170519(21)7CHS1790
(01)04251285200234(11)170508(21)7CHS1764
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(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
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(01)04251285200234(11)200629(21)0CHS4297
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(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
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(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
|
Recalling Firm/
Manufacturer |
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
|
| For Additional Information Contact | Fresenius Medical Care Technical Service
800-553-1109 |
|---|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Fresenius Medical issued Urgent Medical Device Correction letter (FA-2022-16-C) on 6/16/22. Letter states reason for recall, health risk and action to take:
DO NOT TOUCH THE ETHERNET PORT ON THE BACK OF THE MACHINE.
" If your ethernet port cover is not covered by the enclosed cover, unplug the machine, and carefully cover it without touching the ethernet port.
" Do not perform any service to the device requiring you to connect an ethernet cable to the device. Do not attempt to download FTP files via the ethernet cable.
" You may continue to use the device until the device correction is made.
A Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service Specialist will be contacting you to schedule a correction of your portable Water Treatment system. If choosing to correct via your own Certified AquaC UNO H System Technician, you will need to contact FMCRTG prior to performing the correction. FMCRTG will provide the necessary instruction via a Change Notification. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service Specialist may perform this service.
For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109. |
|---|
| Quantity in Commerce | 318 units |
|---|
| Distribution | US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = FIP
|
|---|
