Z-0259-2020Class II

Various products which were contract sterilized

Name: Z-0259-2020 Various products which were contract sterilized
Creator: Anewmed Corporation
Published: 2019-05-23
License: https://open.fda.gov/license/

Anewmed Corporation / initiated 2019-05-23 / Open, Classified / root cause: packaging

FDA source

Anewmed Corporation began a recall of Various products which were contract sterilized on 2019-05-23. FDA classified it as Class II and gives the reason as "The contract sterilizer did not have adequate packaging data to support the 2-year shelf life". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0259-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-23
Posted: 2019-10-31
Recalling firm: Anewmed Corporation
Product: Various products which were contract sterilized.
Product code: DQX Wire, Guide, Catheter
Reason for recall: The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
Root cause tag: packaging
FDA root cause: Other
Action: AnewMed Corporation notified customers on about 05/23/2019 via "URGENT NOTICE VOLUNTARY RECAL OF MEDICAL DEVICES" letter sent certified mail. Instructions included to examine inventory for affected devices and either return them to AnewMed for a credit or destroy them. Customers were also instructed to complete and return the provided Reply Card and indicate whether devices will be return or have been discarded. Questions or additional details can be obtained from Rob Bennison or Nykysha Anderson at 770-263-9633, Monday-Friday, 8:30 AM to 4:40 PM Eastern Time.
Quantity in commerce: 1,749 devices
Distribution: Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.
Product codes and lots: Product Number (Lot Code): 1. G26862 (W3915653); 2. 8065751801 (15027297X-2015-06); 3. E7924 (HD1206703); 4. MCFK64 (MBKY190); 5. PCB502090 (16105672, 17525844); 6. PCB602090 (17766962, 17716501, 17505067, 17465154, 17339717, 17191941, 16536005, 15473410, 15441264, 16685888); 7. PCB702090 (16722293); 8. 277-10-50 (12094017); 9. 420024 (73B1500332); 10. 160636 (1202143, 1109213), 11. 160656 (1208163); 12. 7210424 (50506601); 13. AD750-KE40 (169-16), AD750-KE35 (182-16); 14. AD750-KE30 (102-16); 15. AD750-KE35 ( 118-16); 16. 614-481 (648221); 17. 76353200M (208992282, 207180152, 206969148, 206110579); 18. ASHA4250-01 (2004847); 19. GN1000 (9592565); 20. GN1500 (9916746); 21. SK200 (9577286); 22. GN2000 (9909194); 23. 9-AVP2-014 (1204040241); 24. 9-AVP2-016 (1201055704); 25. 401814RMC (35227834); 26. EICA5872-01 (1035512, 1049334, 1046764, 1050636); 27. 1011895H (141110A081); 28. 10031 (AM043619); 29. 424-7020W (17022849); 30. 424-5020W (17144227); 31. 115321 (HUUG0824), 115311 (HUTJ0689); 32. 96830-012 (12071254); 33. 96880-021 (2016120999); 34. OMS-T10BT ( P6J0204X, P6M0586X, P6H0631X); 35. 113230 (HUZH2232, HUZF1409, HUZI1854); 36. 681 (HUWB1603 ); 37. S11886001 (HUWB1085); 38. G09691 (5335591); 39. G27023 (5094825); 40. G11672 (5425109, 5201291); 41. KD-V431M-0720 (73V, 72V, 76V); 42. KD-V411M-0730 (71V, 6ZV); 43. 8065750352 (1642344H); 44. 260-120 (15603764); 45. G53025 (4414833); 46. 82-1735 (CNCDBF); 47. 134450 (HUWA0947, HUVJ0726, HUVA1707); 48. CQF7554 (REYF0349); 49. CS40G (F4PE3M, F4PF8T); 50. M00530880 (G65382, G43088); 51. M00530870 (3888336, 788930, G43096, G59523); 52. G22732 (W3627617, W3665361, W353500, W3655212, W3531994); 53. G21765 (W3775367, W3611934); 54. 2124 (MN14080, MN13391); 55. 2296-100-216 (12034017); 56. PCB802090 (17747960); 57. 112750 (HUVJ1411, HUVF1668, HUUJ1326, HUTG1189, HUTE0455, HUSL1081); 58. 70138014 (531003018); 59. 70138001 (619552823); 60. 70138033 (640797753); 61. D-201-12704 (46K); 62. 24009 (2014011549); 63. G25671 (C1305047, C1314474, C1320703); 64. G25672 (C1162486, C1160026); 65. 5614 (20249064); 66. 91-12504 (6000004655); 67. SRK30 (MO27683); 68. 105-5092-150 (A096597); 69. ECR60W (L4EE9G, J4AE6D, K4DP4M, K4CC4H); 70. EC45A (K4CZ96); 71. EGIA45AMT (N2E0120ULX); 72. 30453 (N9L0087); 73. 30453 (N9A14); 74. 30453 (N2F0101LX); 75. 30453 (N2B0429LX); 76. 30453 (N1L0731LX); 77. 30453 (N1H0786LX); 78. 30453 (N1H0728LX); 79. 30453 (N5E0943KX); 80. 30453 (N1H0296LX); 81. 30453 (N1G0663LX); 82. 30453 (N1F0631LX); 83. 30453 (N0L0261); 84. 30453 (N0K0525); 85. 30453 (N1C0147LX); 86. 30453 (N3C0249LX); 87. 30453 (N2K0152LX); 88. 30453 (N2J0639LX); 89. 30453 (N4L0080KX); 90. 30453 (N2B0265LX); 91. 30453 (N1M0234LX); 92. 30453 (N1H0494LX); 93. 30453 (N1D0605LX); 94. 30453 (N9G0020); 95. 30453 (N8C413); 96. 30453 (N3F0179LX); 97. 30453 (N3B0327LX); 98. 30453 (N2F0340LX); 99. 30453 (N3E0189LX); 100. 30453 (N2C0297LX); 101. 30453 (N1L0474LX); 102. 30453 (N1G0249LX); 103. 30453 (N3D0092LX); 104. 30453 (N2F0194LX); 105. 30453 (N1F0422LX); 106. 30453 (N0F0164); 107. 30453 (N2B0529LX); 108. 30453 (N1F0767LX); 109. 173016 (N2F0618X); 110. 174601 (P2J0627X); 111. 30453 (N3C0405LX); 112. 30453 (N3A0707LX); 113. 30453 (N3A0221LX); 114. 30453 (N2K0401LX); 115. 30453 (N2G0538LX); 116. 30453 (N1M0112LX); 117. 30453 (N1H0900LX); 118. ECS33A (J4AT7Z, J4AG4G); 119. VH-3200 (25126202); 120. M00582080 (925804); 121. 711145 (1412697); 122. ATS45 (K4C81P); 123. 168190 (18673916); 124. 1000-90 (ELV32219V, ELV32215V); 125. G12830 (5204864); 126. OMS-XB2 (P6E0652X); 127. 3932 (20769076); 128. G11638 (5138842); 129. G30393 (U2102887, U2018952); 130. CBM320010 (16933371); 131. CBM325010 (15280044); 132. CBM325006 (13530853); 133. CBM330006 (16816611); 134. CBM340010 (17078794); 135. CBM340006 (EH5796); 136. 375-940-000 (12117CE2); 137. G49572 (W3357124, W3908339, W3816378); 138. G48277 (W3905583, W3915008, W3989699); 139. G48278 (W3852820, W3835461, W3856129, W3849232, W3864789); 140. G50977 (W3797199, W3771825, W3763156); 141. G31527 (C1287719, C1212820); 142. G31551 (C1384600); 143. G21613 (W3621261, W3746570, W3920476); 144. G21475 (C1103316, C1136032), G21478 (C1222618, C1264137), G21479 (C1291590, C1231802, C1231802, G21480 (C1176271, C1215997, 1404674, C1406615); 145. G21578 (C1168847, C1193440, G21578 (C1349288); 146. G22190 (C1133441, C1181667); 147. G22206 (C1303007, C1151429); 148. G22212 (C1226620, G22212 (C1333128); 149. G22209 (C1159612, C1195005, C1401555); 150. G22210 (C1263370, C1137419, C1398095); 151. G21575 (C1181665, C1264138, C1269765); 152. G21519 (C1208787, C1213739, C1232416); 153. G21513 (C1301561, C1299682); 154. G21515 ( C1398174, C1407597, C1395555); 155. G49669 (W3887185, W3734144, W3830265, W3926266); 156. G49670 (W3581229); 157. CGG100 (54044, 51496A, 53702, 50866, 27610, 42562); 158. 320401 (17379413); 159. 7741800 (REXC0461); 160. 607780 (REWK0266); 161. 5573 (588107, 589892); 162. 395680 (11007102); 163. TVTOML (3900615, 3899051); 164. 400272 (M10100920, M10120628, M10100810, M10140620); 165. ACE14S (G4RT4H, G4T19L); 166. 180-1022 (FPCANL0268); 167. 1001780-HC (4091671, 5061571); 168. 2078175 (5081171, 5072071, 5090971); 169. 1010483-HJ (5051171); 170. 1005205 (5091561); 171. 1003282 (5092561); 172. 22299M-W30 (6111761); 173. 6201-3-410 (12129012); 174. G24885 (W3853601, W3853606, W3851164, W3867041); 175. 104-4112 (A087529, A038510); 176. 85424 (1088647119); 177. 85418 (1085516308); 178. 711652 (1713264); 179. E1455B-4 (235763X, 226079X, 228816X, 239497X); 180. CD001 (1216048, 1215253, 1199796, 1203175); 181. CFS02 (1233768); 182. C0R47 (1157155, 1193379, 1170526, 1270156, 1161400, 1185534, 1189155, 1187909, 1167792, 1162462, 1162462, 1189155, 1184124, 1215318); 183. CTF04 (1200811, 1212288, 1212288, 1212288, 1200811); 184. CFF04 (1169744); 185. CFF03 (1176603, 1202129, 1215444, 1218641, 1198864); 186. CTF73 (1215460, 1194868, 1224514, 1226721, 1213437); 187. AR-4515 (557146); 188. 10237 (AA5096R08, 10237-02); 189. 518-024 (FLG15L02A); 190. G24974 (W3594401, W3594783); 191. EX071201CS (ANZB1469); 192. ER420 (J4AV0H, H44W8T); 193. LS1037 (S1H0032PX, S1H0019X, S0E0028, S2M0033X); 194. LF1637 (53230080X, 52820157X); 195. 518-018 (FLA15K16A); 196. 518-019 (FLC15L02A); 197. 1423002 (59661500, 59735400); 198. 19716 (50832316); 199. 150-FT-Q (172001); 200. 2296-3-114 (11290017); 201. G21544 (W3535506); 202. 0120-16-1.5 (AA5279F01 ); 203. 0120-18-1.7 (AA5299F01 ); 204. 15CY50 (6429530); 205. MS100703 (P1F1027, P1J0791); 206. GBC250 (ML-000277, ML-000249, ML-000189, ML-000256, ML-000174, ML-000189, ML-000273, ML-000243, ML-000187, ML-000279, ML-000257, ML-000220, ML-000276); 207. 900-517 (159207); 208. 39171-07047 (16986805); 209. 39171-06047 (16986393); 210. 39171-04027 (17049224); 211. G21586 (C1252525, C1315989, C1302124 ); 212. G21466 (1276842, C1261496, C126230); 213. RFX058-115-08 (A455804); 214. 18INFKIT (214140473); 215. G25660 (C1402377 ); 216. G25382 (C1401568 ); 217. G25380 (C1414580); 218. G25381 (C1260061, C1402671, C1407944, C1407944); 219. G25385 (C1248163, C1323760, C1292424); 220. G25379 (C1405595, C1404673); 221. G25384 (C1125120, C1203676, C1256105), G25386 (C1099170, C1250427); 222. G25383 (C1273638); 223. G25657 (C1354804, C1385183); 224. G25659 (C1366014, 1268288); 225. G25656 (C1311926, C1275747, C1136905, C1256091); 226. G25658 (C1201058, C1208788, C1395563); 227. WA33025A (175W); 228. 17301 (18557220); 229. WA33035A (176W); 230. G22189 (C1125118, C1266773, C1297687, C1307476); 231. OMS-PDBS2 (P3F0171X, P3F0170X, P3D212, P3D0773X, P3C0202X, P2M131, P2J1038, P2D0443, P2C0072, P1J0129, P1G0194, 481955, P8H0561,P4J0179X, P1K0483, P4H0281X, P3E0533X, P2H0933); 232. 175-254 (17063324); 233. PCB8020135 (16734263, 13887299); 234. RSS502 (UA20); 235. RSS002 (TE22); 236. RSS902 (TD11, RN19); 237. RSB501 (TD1113); 238. RSB801 (TA2813, TC2513); 239. RSB701 (TA0713); 240. 920010PK (128795JB, 128795JB, 115548GB, 474366GE); 241. EIC5872-01 (B213000-A); 242. G00213 (3497284); 243. 192-121 (16606789); 244. 7003D (18028705); 245. 134048 (P2F0202X); 246. EICA8875-01 (1045592, 1032335, 1055696, 1033044); 247. EICA7070-01 (1050150); 248. 50325 (1405121), 50330 (1403101); 249. MC*PE28131YB (141219, 141219); 250. MC*PB2813Y (141222, 150119); 251. 174006 (P2D0471X); 252. TCR75 (H44T2L); 253. TRT75 (J4AD0L); 254. TL60 (H44538); 255. G21771 (C1398159, C1415073); 256. G22656 (W3354217, W3798838, W3790897, W3859077); 257. G22657 (W3566556, W3861550); 258. G22654 (W3341373, W3920057, W3914521 ); 259. G22655 (W3375861, W3848989, W3806105, W3844678); 260. 518-088 (FSU15E15A); 261. 518-037 ( FQQ15J02A, FQQ15K05A, FQQ15M17A, FQQ14J25A, FQQ14E02A, FQQ15A27A); 262. 518-038 (FQR15K16A, FQR15K01A); 263. G24925 (W3454936); 264. CG417 (130620, 120821, 130830, 130207, 121219, 140717, 131018, 131001, 130725, 120713, 131226, 110804, 100604, 130826, 120512, 140425); 265. GS3508 (151109, 150819); 266. GS3509 (150407, 141117, 150408, 141106, 120327, 101116, 131226, 100527, 120907, 121016, 141001, 140708, 140211, 140929); 267. SU130-1113 (1120469); 268. EICA4845-01 (1061207, 1047446, 1040062); 269. EICA4835-01 (1054511); 270. RS0516M (130612B-CM, 130326C-CM); 271. FG-V421PR (74K); 272. 9010M0 (100071249, 100069621, 100068425, 100067769); 273. G22419 (W3918641, W3845062, W3837781, W3912321); 274. 174213 (P2M0543X ); 275. KC-RUMI-35 (164124); 276. 5100-137-133 (11311027); 277. 4627 (19359482); 278. PR-420Q (63K, 65K); 279. FD-410LR (42K, 43K); 280. FD-411UR (44K, 46K); 281. HX-201UR-135L (47V); 282. 10709703 (4799520); 283. G21573 (W3808773, W3924304); 284. G21571 (W3729654); 285. G22062 (W3779758, W3788553); 286. 117009 (HUWA0774, HUVI0127, UWA1728); 287. 81014 (U2471787); 288. OMS-T10SB (P3B0513X, P3F0036X, P2A0939, P1M0208, P3E0229X, P4E0323X, P4D0723X, P4D0154X, P4C0190X, P3B0513X, P4D0720X, P2C0809X, P2A0938, P3G0034X, P2K0820X, P2F0093X, P2F0187X, P3A0676X, P3B0237X, P3L0024X); 289. 3570 (21308654); 290. 540-011 (FRM15J16A); 291. 545-511 (FRK15K13A); 292. 545-513 (FRJ15K20A); 293. G26862 (W3817189, W3912855, W3817181, W3911176); 294. 46805 (18331493); 295. 46-808 (17673839); 296. G22555 (W3603898); 297. 7209509 (G21535); 298. 423-135-01 (FBL14A20A, FBL15C13A, FBL15G14A, CBL15E19C); 299. 410-154 (FBE12L15J, F11E11C, FBE15F11A, FBE13M09A); 300. 414-159 (BF13L14A, FBF14M03A, FBF13A15G, FBF12M03E, FBF15A06A, FBF15D20A); 301. 420-159 (FBH15F03B); 302. 423-001 (FBC13J20B, FBC13J24A, FBC13F18B, FBC14A28A); 303. 414-151 (F08K14B, C08F16F, FAY13M18A, FAY12L05H, F12J26E); 304. 417-152 (F08L24A, C08F19A, FAZ14A09B, FAZ14A30A, FAZ13L08A, FAZ13A24D, F10E06B); 305. 410-152 (080319A, 080611F, FBD13F20A, FBD14L19A, FBD14B28C, F12E25A, F11L01E); 306. 425-011 (FBJ12C28G, FBJ12L01D, F11E17D); 307. 420-006 (FBA15A16A, F09L24D, F12J12C, FBA15F01B, 080604B); 308. 72201491 (50422995); 309. 72201490 (50417508); 310. 12401808 (4814340); 311. 12401810 (606786); 312. 12401807 (4814344); 313. 225-118 (16878791); 314. E3310 (S2FE002X, S2GE005X, S2EE007X); 315. VH-3200 (25003515, 25123871, 25113704, 25112172, 25078222, 25003515, 25111149, 25100397, 25004271, 25126067); 316. VH-4000 (25098259); 25101219, 25085248, 25085248, 25029979, 25124269, 25099863, 25034100, 25118688, 25104986, 25124269, 25085248, 25029979, 25034100, 25085248, 25101219, 25085248, 25085248, 25085248, 25103910, 25123811, 25085248, 25070210, 25101219, 25099863, 25085248, 25085248, 25085248, 25085248, 25099863, 25126066, 25099863, 25104986, 25101219, 25103910, 25085248, 25112813, 25104807, 25122851, 25097420, 25104986, 25119805, 25099863, 25097420, 5124269, 25104986, 25101219, 25104986, 25104986, 25085248, 25085248, 25085248, 25104986, 25085248, 25085248, 25099863, 5126066, 25104986, 25123811, 25085248, 25124004, 25090702, 25121223, 25101219, 25119805, 25090702, 25118577, 25070216, 25119001); 317. 10302 (HUUJ0479); 318. VS101011P (P1K0305); 319. VS101500 (P2G0750X); 320. G-260-2545A (79K, 7XK, 78K, 7XK); 321. G-240-2545S (71K, 77K, 78K); 322. 88901 (023250031333060, 023250025944120); 323. 501-116 (FLM15H15A); 324. 501-114 (FMM15L03A); 325. 501-112 (FSM15K30A); 326. 403-8553R (16100646); 327. WWFS35145 (10396727, 10367451); 328. 103-0605-200 (201502217E); 329. G21393 ( C1314141); 330. G22982 (C1175173, 1204976); 331. G24565 (C1210197, C1306730, C1191869, C1349637); 332. G24707 (CF1234331);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0259-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0259-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code DQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)