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.
This recall has been terminated (originally issued April 22, 2013).
- Company
- Teleflex Medical
- Recall Initiated
- March 28, 2013
- Posted
- April 22, 2013
- Terminated
- May 1, 2014
- Recall Number
- Z-1158-2013
- Quantity
- 190,103
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Sterile packaging may be compromised.
Distribution
Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.