PORTEX Bivona Tracheostomy Silicone Tube recall
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF…
Why was PORTEX Bivona Tracheostomy Silicone Tube recalled?
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) UDI/DI 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458; b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers: 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 3839572, 3845070, 3849724, 3852697, 3870312, 3870313, 3870314, 3870315, 3870316, 3870317, 3870318, 3870319, 3897727, 3901072, 3901073, 3904426, 3939373, 3942402, 3952277, 3962454, 3973201, 3980528, 3988247, 3991258, 3991639, 4005726, 4008258, 4008259, 4008260, 4018554, 4021437, 4026720, 4033787, 4067208, 4070878, 4096871, 4097851, 4101024, 4107646, 4115311, 4117748, 4122529, 4128080, 4131075, 4134121, 4136191, 4139082, 4142533, 4145790, 4148043, 4151104, 4153681, 4171674, 4171675, 4173694, 4176260, 4178829, 4185497, 4192841, 4197661, 4197662, 4257859, 4263229, 4283185, 4309561, 4331671, 4363783, 4366576, 4376167, 4384907, 4393384; c) UDI/DI 15021312006421, Product Code/List Number/Item Code 750180, lot Numbers: 3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3797125, 3800602, 3801535, 3801536, 3801537, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3839573, 3839574, 3839575, 3870213, 3870214, 3870215, 3870216, 3870217, 3870218, 3870219, 3870220, 3870221, 3894701, 3894702, 3894703, 3894704, 3894705, 3894706, 3901032, 3901033, 3904488, 3904489, 3952216, 3952217, 3959218, 3962463, 3984950, 3988248, 4002283, 4002284, 4002285, 4005749, 4005750, 4015644, 4015645, 4021438, 4021439, 4033788, 4046816, 4054563, 4077143, 4080839, 4083962, 4092689, 4095943, 4096887, 4097852, 4105325, 4107661, 4110491, 4119152, 4125917, 4128114, 4131094, 4136209, 4139048, 4163867, 4168109, 4173695, 4178830, 4180539, 4185498, 4192842, 4192843, 4201737, 4205254, 4216366, 4229366, 4233997, 4242056, 4255460, 4291924, 4293044, 4331672, 4335537, 4346834, 4371674, 4371675, 4390913, 4391733, 4393385, 4393386, 4401163
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF…
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 25283 units
- Distribution
- Worldwide distribution.
- Recall date
- September 4, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)