Class 2 Device Recall Various Surgical Devices.

• Date Initiated by Firm: May 23, 2019
• Create Date: October 31, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0259-2020
• Recall Event ID: 83001
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: Various products which were contract sterilized.
• Code Information: 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)
• Recalling Firm/ Manufacturer: Anewmed Corporation; 2177 Flintstone Dr Ste O; Tucker GA 30084-5000
• For Additional Information Contact: 770-263-9633
• Manufacturer Reason for Recall: The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
• FDA Determined 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.
• 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.