Name: Various products which were contract sterilized.
Brand: Anewmed Corporation

Reason for Recall

The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

Distribution

Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.

Lot / Code Info

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);

Root Cause

Other

Action Taken

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.