Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is pac...
FDA Device Recall #Z-1309-2018 — Class II — September 14, 2017
Recall Summary
| Recall Number | Z-1309-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 14, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard, Inc. |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 10,949,013 units in total |
Product Description
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.
Reason for Recall
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
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
Lot / 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
Other Recalls from C.R. Bard, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1431-2021 | Class II | Bard Clean-Cath Intermittent Catheter, 12 Frenc... | Jan 11, 2021 |
| Z-1355-2018 | Class II | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0... | Feb 27, 2018 |
| Z-1357-2018 | Class II | Bard(R) Premature Infant Feeding tube, ENFit(TM... | Feb 27, 2018 |
| Z-1354-2018 | Class II | Bard(R) Premature Infant Feeding Tube, ENFit(TM... | Feb 27, 2018 |
| Z-1356-2018 | Class II | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM)... | Feb 27, 2018 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.