Z-0178-2022 Class II Terminated
FDA device recall Z-0178-2022 was initiated by Smiths Medical ASD Inc. on August 9, 2021 and is designated Class II. Reason for recall: Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. The recall status is terminated (terminated October 13, 2023). Affected quantity: 2191 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 3, 2021
- Initiation Date
- August 9, 2021
- Termination Date
- October 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2191 devices
Product Description
Bivona Uncuffed Wire Endotracheal Tubes,
Reason for Recall
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.
Code Information
SKU 15W080 Lots #'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. SKU 15W085 SKU 15W090 SKU 15W095