Z-1158-2013Class II

Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects...

Name: Z-1158-2013 Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects...
Creator: Teleflex Medical
Published: 2013-03-28
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2013-03-28 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 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... on 2013-03-28. FDA classified it as Class II and gives the reason as "Sterile packaging may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1158-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-04-22
Terminated: 2014-05-01
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.
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Reason for recall: Sterile packaging may be compromised.
Root cause tag: manufacturing process
FDA 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 in commerce: 190,103
Distribution: Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1158-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1158-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-22

Product code KNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)