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Smiths Medical ASD Inc. Recall 88512

Description: Bivona Uncuffed Wire Endotracheal Tubes,

Smiths Medical ASD Inc. Recall 88512 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0178-2022
Event ID88512
Event DescriptionBivona Uncuffed Wire Endotracheal Tubes,
Product TypeDevices
DistributionWorldwide 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.
Quantity2191 devices
Recall ReasonInadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Device Classification20211103
Device Code InfoSKU 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 Date20211027
Recall Initiation Date20210809
Recalling FirmSmiths Medical ASD Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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