Recalls / —
—#188884
Product
Bivona Uncuffed Wire Endotracheal Tubes,
- FDA product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K792035
- Affected lot / 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
Why it was recalled
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Root cause (FDA determination)
Process control
Action the firm took
Instructions to Consignees 1. Locate and quarantine affected product in your possession. 2. Determine the number of affected devices in your possession and complete the Response Form 3. All affected product must be returned to Sedgwick for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. Instructions to Distributors DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- 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.
Timeline
- Recall initiated
- 2021-08-09
- Terminated
- 2023-10-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188884. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.