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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64715

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

1 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 1

Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.

Z-1158-2013
Recall number
Z-1158-2013
Initiated
March 28, 2013
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
190,103

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile packaging may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile packaging may be compromised.

Code information

CATALOG NO. B1000 - 02A1100488, 02A1100489, 02A1100490, 02A1100491, 02A1100492, 02A1101420, 02A1101421, 02A1102009, 02A1102010, 02A1102049, 02A1102050, 02A1103180, 02A1103181, 02A1103182, 02A1201862, 02A1201868, 02A1201869, 02A1201870, 02A1201871, 02A1202372, 02A1202373, 02A1202374, 02A1202376, 02A1202377, 02A1202378, 02A1202603, 02A1202632, 02A1202633, 02A1202634, 02A1202783, 02A1202784, 02A1202785, 02A1202786, 02A1202787, 02A1202788, 02A1202789, 02A1202790, 02A1202791, 02A1202792, 02A1203552, 02A1203553, 02A1203554, 02A1203555, 02A1203556, 02A1204179, 02B1100522, 02B1100523, 02B1100524, 02B1101000, 02B1101001, 02B1101002, 02B1102328, 02B1102329, 02B1103007, 02B1200105, 02B1200106, 02B1200107, 02B1201685, 02B1201686 02B1201687, 02B1201688, 02B1201689, 02B1202029, 02B1202508, 02B1202509, 02C1000808, 02C1000910, 02C1000911, 02C1000912, 02C1001699, 02C1001725, 02C1002642, 02C1002655, 02C1002656, 02C1002657, 02C1002990, 02C1003816, 02C1003817, 02C1003818, 02C1100328, 02C1100329, 02C1100330, 02C1100331, 02C1103877, 02D1000274, 02D1000982, 02D1000983, 02D1002061, 02D1002062, 02D1002063, 02D1002753, 02D1002754, 02D1002755, 02D1200734, 02D1200735, 02D1200736, 02D1200737, 02D1203071, 02D1203072, 02D1203073, 02D1203074, 02D1203075, 02D1203084, 02E1002077, 02E1002746, 02E1002747, 02E1102105, 02E1102106, 02E1102107, 02E1102346, 02E1102347, 02E1102348, 02E1102349, 02E1102350, 02E1103220, 02E1103221, 02E1103222, 02E1103223, 02E1103225, 02E1200137, 02E1200138, 02E1200139, 02E1200140, 02E1200141, 02E1200142, 02E1200143, 02E1200144, 02E1201212, 02E1201234, 02E1201235, 02E1201236, 02E1201237, 02E1201238, 02E1201811, 02E1201812, 02E1201813, 02E1201983, 02E1201984, 02E1201985, 02E1201986, 02E1201987, 02E1201988, 02E1201989, 02F1000379, 02F1000380, 02F1001044, 02F1001045, 02F1001046, 02F1001801, 02F1001802, 02F1002742, 02F1002743, 02F1002744, 02F1003780, 02F1003781, 02F1003782, 02F1101266, 02F1102102, 02F1102107, 02F1102108, 02F1103126, 02F1103127, 02F1103128, 02F1103129, 02F1103566, 02F1103567, 02F1103568, 02F1103569, 02F1201733, 02F1202628, 02F1203156, 02F1203157, 02G1000133, 02G1000134, 02G1001110, 02G1001111, 02G1001112, 02G1001113, 02G1001114, 02G1001571, 02G1001572, 02G1002676, 02G1002677, 02G1002678, 02G1100575, 02G1100576, 02G1100577, 02G1100578, 02G1100579, 02G1200760, 02G1200771, 02G1200772, 02G1200773, 02G1200774, 02G1200775, 02G1201730, 02G1201731, 02G1201732, 02G1201733, 02G1201734, 02G1201736, 02G1202202, 02G1202203, 02G1202204, 02G1202205, 02G1202206, 02G1202207, 02G1202821, 02G1202822, 02G1202823, 02G1202824, 02G1202825, 02G1202826, 02H1000671, 02H1000672, 02H1000673, 02H1000674, 02H1000720, 02H1000721, 02H1000722, 02H1000723, 02H1001458, 02H1001459, 02H1001460, 02H1002831, 02H1002832, 02H1002833, 02H1100924, 02H1100925, 02H1100926, 02H1101672, 02H1101673, 02H1101674, 02H1101675, 02H1101676, 02H1102339, 02H1102340, 02H1102625, 02H1102626, 02H1102627, 02H1200264, 02H1200265, 02H1200267, 02H1200272, 02H1200275, 02H1201461, 02H1201462, 02H1201463, 02H1201464, 02H1201465, 02H1201466, 02H1201803, 02H1201804, 02H1201805, 02H1201806, 02H1201807, 02H1201809, 02H1202365, 02H1202367, 02H1203113, 02H1203114, 02H1203115, 02J1000130, 02J1000131, 02J1000132, 02J1000133, 02J1001054, 02J1001055, 02J1001056, 02J1001459, 02J1001460, 02J1001461, 02J1001662, 02J1001792, 02J1001793, 02J1002994, 02J1002995, 02J1003183, 02J1003184, 02J1003947, 02J1003948, 02J1101101, 02J1101102, 02J1101103, 02J1101104, 02J1101105, 02J1101766, 02J1101767, 02J1101768, 02J1101769, 02J1102135, 02J1102519, 02J1102520, 02J1102521, 02J1102524, 02J1103393, 02J1103394, 02J1103395, 02J1103396, 02J1103397, 02J1201479, 02J1201481, 02K1000440, 02K1000441, 02K1001417, 02K1001418, 02K1002226, 02K1002227, 02K1002623, 02K1003132, 02K1003133, 02K1003134, 02K1003595, 02K1100719, 02K1100720, 02K1100721, 02K1100722, 02K1100723, 02K1101650, 02K1101651, 02L1000684, 02L1000685, 02L1000686, 02L1000687, 02L1000688, 02L1001189, 02L1001190, 02L1002404, 02L1002405, 02L1002406, 02L1003281, 02L1003282, 02M1000051, 02M1000060, 02M1001023, 02M1001024, 02M1001025, 02M1001026, 02M1001573, 02M1001574, 02M1001575, 02M1002665, 02M1002666, 02M1002667, 02M1002668, 02M1002669, 02M1003205, 02M1003206, 02M1003207, 02M1102661, 02M1102662 CATALOG NO. B1000P - 02A1100494, 02A1101101, 02A1102052, 02A1103184, 02A1201872, 02A1202793, 02B1101418, 02B1103009, 02B1202770, 02C1001701, 02C1002644, 02C1002993, 02C1201165, 02C1201848, 02C1202407, 02C1203284, 02D1002064, 02D1002756, 02E1200414, 02F1001047, 02F1001803, 02F1002745, 02F1100453, 02F1100454, 02F1203169, 02G1201452, 02G1202827, 02H1000675, 02H1001461, 02H1002834, 02H1102629, 02J1000134, 02J1003949, 02J1102523, 02K1002158, 02K1002624, 02K1101653, 02L1001192, 02L1002407, 02L1003284, 02L1101573, 02L1101575, 02M1000052, 02M1001027, 02M1001577, 02M1002671, 02M1003210, CATALOG NO. B1000CT - 02A1100493, 02A1101100, 02A1102051, 02A1103183, 02B1101417, 02B1103008, 02E1201810, 02E1202328, 02E1202889, 02F1100452, 02G1101973, 02G1200493, 02G1200494, 02G1200495, 02G1201735, 02G1202208, 02G1202828, 02H1100292, 02H1102628, 02J1001061, 02J1001463, 02K1000442, 02K1001419, 02K1002228, 02L1001191, 02M1001576, 02M1002670, 02M1003209

Distribution pattern

Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.