Recall Z-0178-2022 ยท BTR Tube, Tracheal (W/Wo Connector)
Smiths Medical ASD Inc.
Bivona Uncuffed Wire Endotracheal Tubes,
| Date | Aug 9, 2021 |
| Status | Terminated |
| Reason | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. |
| Root cause | Process control |
| Action | 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 Res |
| Quantity | 2191 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792035 | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE Bivona Medical Technologies, Oct 26, 1979 |