Teleflex Medical: 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.

Recall number

Z-1158-2013

Recalling firm

Teleflex Medical

Product

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.

Status

Terminated

Initiated

2013-03-28

Posted

2013-04-22

Terminated

2014-05-01

Reason

Sterile packaging may be compromised.

Root cause

Nonconforming Material/Component

Action

Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have any of the affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed. If you and your customers have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document your receipt of this letter. To return product complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. If you have any other questions feel free to contact your local sales representative or Customer Service at 1 (866) 246-6990.

Quantity

190,103

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KNX

Firm FEI

3005747797

Firm city

Durham

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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