Reported Nov 3, 2021 · Terminated
Bivona Uncuffed Wire Endotracheal Tubes,
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Bivona Uncuffed Wire Endotracheal Tubes,
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 15W080Lots #'s: 3221795, 3221796, 3226185, 3250343, 3263023, 3272646, 3301497, 3301498, 3312810, 3312811, 3315720, 3315721, 3338833, 3346070, 3361916, 3370107, 3379478, 3433337, 3437237, 3442378, 3442379, 3451013, 3459483, 3463690, 3491443, 3491444, 3491445, 3491446, 3491447, 3491448, 3507938, 3507939, 3507940, 3507941, 3512284, 3512285, 3517254, 3521999, 3531347, 3540954, 3545300, 3552748, 3565644, 3569215, 3582745, 3608114, 3608131, 3615305, 3641651, 3680769, 3700904, 3707798, 3782473, 3790044, 3890025, 3890026, 3890027, 3890028, 3890029, 3890030, 3890031, 3890032, 3890033, 3907873, 3926897, 3985080 and 3991281. 15W085— 15W090— 15W095— - Amount recalled
- 2191 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.