Class 2 Device Recall Personal Intermittent Catheters

• Date Initiated by Firm: September 14, 2017
• Date Posted: April 04, 2018
• Recall Status: Terminated on November 05, 2019
• Recall Number: Z-1309-2018
• Recall Event ID: 78642
• 510(K)Number: K000723 K122785
• Product Classification: Catheter, straight - Product Code EZD
• Product: Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, ; 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616; ; Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
• Code Information: Item Numbers, Lot Numbers: 50612, Lot Numbers: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093, JUBT1089, JUBQ1417, JUBQ1691, JUBR0232, JUAX0761, JUAY0563 50614, Lot Numbers: JUBN0526, JUBR2531, JUBR1271, JUBR2565, JUBS2412, JUBS1262, JUBS1291, JUBS1877, JUBS2411, JUAZ1147, JUAZ1157, JUAZ0147, JUAZ0126, JUAZ1207, JUAZ1281, JUAZ1275, JUAZ1252, JUBN0077, JUBN0049, JUBN0490, JUBN0824, JUBN0850, JUBN1022, JUBP0035, JUBP0063, JUBP1202, JUBP0194, JUBP0224, JUBQ0039, JUBP0674, JUBQ0024, JUBP1182, JUBQ0076, JUBQ0091, JUBP0699, JUBQ1023, JUBQ1390, JUBQ1673, JUBR0853, JUBQ1416, JUBQ1690, JUBR0883, JUBR0256, JUBR1245, JUBR2530, JUBT1055, JUBU0498, JUBS1905, JUBS2449, JUAW1103, JUAW1105, JUAW1200, JUAW1201, JUAW1209, JUAW0726, JUAX0275, JUAX0174, JUAX0276, JUAX0679, JUAX0680, JUAX0759, JUAX0745, JUAY0141, JUAY0163, JUAY0468, JUAY0451, JUAY0587, JUAY0685, JUAY0655, JUAY0930, JUAY0911, 53621355 50616, Lot Numbers: JUBS1263, JUBT0121, JUAZ1148, JUAY0931, JUAZ1208, JUAZ0148, JUBN0078, JUBP0064, JUBN0491, JUBN0851, JUBN0825, JUBN1023, JUBN0999, JUBP0701, JUBP1203, JUBQ0092, JUBP1183, JUBQ1024, JUBQ1368, JUBQ1395, JUBQ1686, JUBR0890, JUBR0860, JUBS2409, JUBS2410, JUBS2447, JUBT0161, JUBT0162, JUBR0257, JUBR0373, JUBR1272, JUBS0439, JUBS0469, JUAX0175, JUAX0176, JUAX0277, JUAX0177, JUAX0708, JUAX0747, JUAX0681, JUAY0142, JUAY0469, JUAY0588, JUAY0664 50618, Lot Numbers: JUBP0226, JUBQ0980, JUBQ1859, JUBN0016, JUBN0014, JUBN0015, JUAW0697, JUAV1056, JUAY0161 52306, Lot Numbers: JUBN1018, JUBT1763, JUAX0732 52308, Lot Numbers: JUBS1903, JUBS1875, JUBN0995, JUBP0951, JUBS1874, JUBT1802, JUAU0446, JUAU0552, JUAZ1194 52310, Lot Numbers: JUBP0953, JUBS1898, JUAX0731 52606, Lot Numbers: JUBU0935, JUAW0971, JUAX0265 52606G, Lot Numbers: JUBS2408, JUAZ1226, JUBP0219, JUBQ0984, JUBR0226 52608, Lot Numbers: JUBQ1419, JUBR0884, JUAU0553, JUAU0559, JUAU0728, JUAV0279, JUAV0683, JUAW0407, JUAW1128, JUAX0198, JUAX0205 52608G, Lot Numbers: JUBP0189, JUBQ0071, JUBQ1392, JUBQ1013, JUBR0854, JUBR2563, JUBR1243, JUAU0554, JUAV0911, JUAW0425, JUAX0199 52610, Lot Numbers: JUBR2523, JUBN0073, JUAZ1272, JUBN1019, JUBP0324, JUBR2496, JUBU0791, JUAU0730, JUAU0726, JUAV0260, JUAV0649, JUAV0687, JUAY0449, JUAY0662 52610G, Lot Numbers: JUBS1259, JUBS0464, JUAZ1196, JUAZ1248, JUBR0251, JUBQ1420, JUBR0885, JUBU0790, JUAU0476, JUAV0449, JUAV0674, JUAW0408, JUAX0741, JUAZ1197 53314, Lot Numbers: JUAV0148, JUAV0149, JUAV0150, JUAX0112, JUAX0110, JUAX0111, JUAY0532, JUAY0533, JUAY0534, JUAY0013, JUAY0014, JUAY0015 53320, Lot Numbers: JUBT1734, JUAY0530, JUAY0531, JUBT1843, JUBU0095, JUAX0108, JUAX0109, JUAY0011 53514G, Lot Numbers: JUBU0093 53610, Lot Numbers: JUBT1143, JUBT1733 53610G, Lot Numbers: JUBT0224, JUBP0187, JUBQ1858, JUAX0385, JUAY0861 53612G, Lot Numbers: JUBT0494, JUBT1714, JUBN0005, JUBN0945, JUAY0860, JUAZ0106 53614G, Lot Numbers: JUBT0487, JUBT0522, JUBT0523, JUBT0831, JUBT0926, JUBT0927, JUBT1312, JUBT1712, JUBT1313, JUBT1759, JUBT0524, JUBT0832, JUAZ1391, JUBN0105, JUBN0079, JUBN0050, JUBN0655, JUBN0656, JUBN1000, JUBP0188, JUBP0037, JUBP0196, JUBN1024, JUBP0676, JUBQ1044, JUBQ1043, JUBP0702, JUBR1868, JUBR2493, JUBS0025, JUBS1137, JUBS1256, JUBU0109, JUBR0481, JUAW0634, JUAW0635, JUAW0636, JUAW0788, JUAw0637, JUAW0890, JUAW0787, JUAW0889, JUAW0992, JUAW0993, JUAW1063, JUAW1064, JUAU0701, JUAX0125, JUAX0126, JUAX0404, JUAX0405, JUAX0656, JUAX0702, JUAX0682, JUAY0143, JUAX0760, JUAY0164, JUAX0402, JUAY0564, JUAY0589, JUAY0628, JUAY0633, JUAY0634, JUAX0401, JUAY0665, JUAY0863, JUAY0868, JUAY0932, JUAZ0127, JUAZ0149, JUAZ1149, JUAZ1158, JUAZ1254 53616G, Lot Numbers: JUBS2133, JUBT0833, JUBT0834, JUBT0923, JUBT2258, JUBN0347, JUBN0001, JUBP0677, JUAW0891, JUAX0178, JUAX0394, JUAX0395, JUAX0655, JUAX0683, JUAX0684, JUAX0746, JUAY0144, JUAY0165, JUAY0452, JUAY0470, JUAY0590, JUAY0565, JUAY0666, JUAY0862, JUAY0913, JUAZ1150, JUAZ0128, JUAZ1159, JUAZ1209 53618G. Lot Numbers: JUBT0924 62308, Lot Numbers: JUBS1316 62310, Lot Numbers: JUBP0325, JUAW0903, JUAX0733, JUAW0709, JUAW0932 62606P, Lot Numbers: JUAY0694 602608, Lot Numbers: JUAW0972, JUAV0481, JUAV0482, JUAV0483, JUAX0240 62608P, Lot Numbers: JUAV0269, JUAV0811, JUAX0089 62610, Lot Numbers: JUBP0327, JUAX0079, JUAX0241 62610P, Lot Numbers: JUBP0190, JUAU0731, JUAW0954 63310, Lot Numbers: JUBT1758 63316. Lot Numbers: JUBT0001 63610, Lot numbers: JUBT1747, JUAX0685 63610M, Lot Numbers: JUAX0386 63612, Lot Numbers: JUBN0826, JUBP0947, JUBP0906, JUAY0566, JUAY0635 63612M, Lot Numbers: JUBN0348, JUBR0891, JUBR2557, JUBS0467, JUBQ0040, JUAX0183, JUAX0657, JUAX0200, JUAX0686, JUAY0667 63614, Lot Numbers: JUBP0030, JUBP0227, JUBP0955, JUBP0907, JUBR0233, JUAX0687, JUAX0748, JUAY0453, JUAX0762, JUAY0636, JUAY0914, JUAY0933 63614M, Lot Numbers: JUAX0180, JUAX0181, JUAY0166 63616, Lot Numbers: JUBP0948, JUBP0900, JUAX0763, JUAY0471, JUAY0875, JUAY0934 63616M, Lot Numbers: JUBS2445, JUAZ1255, JUAX0182 63618, Lot Numbers: JUAZ0150, JUBN0051, JUBP0703 71410, Lot Numbers: 53617349 72608, Lot Numbers: JUAZ1249, JUBQ0072, JUAV0824, JUAV0898, JUAY0139 72610, Lot Numbers: JUAZ1204, JUBQ1017, JUBQ0021, JUAV0446, JUAW0441 73612, Lot Numbers: JUBU0789, JUAX0005, JUAX0006 73614, Lot Numbers: JUBU0423, JUBS2481, JUAX0003, JUAX0004, JUAX0102, JUAX0103, JUAX0390 73616, Lot Numbers: JUBT0234, 53621167
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: BMD Recall Coordinator; 800-793-8110
• Manufacturer Reason for Recall: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
• FDA Determined Cause: Process control
• Action: A notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.
• Quantity in Commerce: 10,949,013 units in total
• Distribution: US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EZD and Original Applicant = ROCHESTER MEDICAL CORP.