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Terminated

Bivona Aire-Cuf Endotracheal Tube

FDA Recall Z-0177-2022 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeBTR
Date Initiated2021-08-09
Date Terminated2023-10-13
Product Quantity7136 devices

Reason for Recall

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

Firm 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 Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K792035FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIREBivona Medical Technologies · 1979-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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