Exact FDA event identifier

Event 78642

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 14, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: C.R. Bard, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

Z-1307-2018

Recall number: Z-1307-2018
Initiated: September 14, 2017
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 44640.0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Code information

Item 50610 Lots #'s: JUBT0404, JUBP0700, JUBR2498, JUBS1289

Distribution pattern

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

device · product 2 of 3

Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

Z-1308-2018

Recall number: Z-1308-2018
Initiated: September 14, 2017
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 10,949,013 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Code information

Item # 50612 Lots #'s: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093, JUBT1089, JUBQ1417, JUBQ1691, JUBR0232, JUAX0761, and JUAY0563 Item # 50614 Lots #'s: 53621355, JUAW0726, JUAW1103, JUAW1105, JUAW1200, JUAW1201, JUAW1209, JUAX0174, JUAX0275, JUAX0276, JUAX0679, JUAX0680, JUAX0745, JUAX0759, JUAY0141, JUAY0163, JUAY0451, JUAY0468, JUAY0587, JUAY0655, JUAY0685, JUAY0911, JUAY0930, JUAZ0126, JUAZ0147, JUAZ1147, JUAZ1157, JUAZ1207, JUAZ1252, JUAZ1275, JUAZ1281, JUBN0049, JUBN0077, JUBN0490, JUBN0526, JUBN0824, JUBN0850, JUBN1022, JUBP0035, JUBP0063, JUBP0194, JUBP0224, JUBP0674, JUBP0699, JUBP1182, JUBP1202, JUBQ0024, JUBQ0039, JUBQ0076, JUBQ0091, JUBQ1023, JUBQ1390, JUBQ1416, JUBQ1673, JUBQ1690, JUBR0256, JUBR0853, JUBR0883, JUBR1245, JUBR1271, JUBR2530, JUBR2531, JUBR2565, JUBS1262, JUBS1291, JUBS1877, JUBS1905, JUBS2411, JUBS2412, JUBS2449, JUBT1055 and JUBU0498 Item # 50616 Lot #'s: JUAX0175, JUAX0176, JUAX0177, JUAX0277, JUAX0681, JUAX0708, JUAX0747, JUAY0142, JUAY0469, JUAY0588, JUAY0664, JUAY0931, JUAZ0148, JUAZ1148, JUAZ1208, JUBN0078, JUBN0491, JUBN0825, JUBN0851, JUBN0999, JUBN1023, JUBP0064, JUBP0701, JUBP1183, JUBP1203, JUBQ0092,J UBQ1024 , JUBQ1368, JUBQ1395, JUBQ1686, JUBR0257, JUBR0373, JUBR0860, JUBR0890, JUBR1272, JUBS0439, JUBS0469, JUBS1263, JUBS2409, JUBS2410, JUBS2447, JUBT0121, JUBT0161 and JUBT0162

Distribution pattern

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

device · product 3 of 3

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.

Z-1309-2018

Recall number: Z-1309-2018
Initiated: September 14, 2017
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 10,949,013 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

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

Distribution pattern

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