FDA Device recall Z-1309-2018

Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers…

FDA Device
Class II
terminated
Published 2018-04-11

On 2018-04-11 the FDA classified a Class II recall of Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers… by C R Bard, citing several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1309-2018
Classification	Class II
Status	terminated
Initiated	2017-09-14
Published	2018-04-11
Last updated	2026-09-13 11:54 UTC
Company	C R Bard
Distribution	US

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.

Reason

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

Identifiers

code_info	Item Numbers, Lot Numbers: 50612, Lot Numbers: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093,… 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,

code_info

Item Numbers, Lot Numbers: 50612, Lot Numbers: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093,…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1309-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.