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Recall Observatory FDA recall evidence

Device product

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Z-0205-2024

August 22, 2023

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 92996
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0205-2024

Official wording

Reason: The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

Code information: Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

Distribution pattern: Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).