Smiths Medical ASD Inc. Recall 88512
Description: Bivona Uncuffed Wire Endotracheal Tubes,
Smiths Medical ASD Inc. Recall 88512 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0178-2022 |
| Event ID | 88512 |
| Event Description | Bivona Uncuffed Wire Endotracheal Tubes, |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 2191 devices |
| Recall Reason | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. |
| Device Classification | 20211103 |
| Device Code Info | 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 |
| Center Classification Date | 20211027 |
| Recall Initiation Date | 20210809 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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