Recall Z-0205-2024— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-08-22. It names one FDA 510(k) clearance: K083641. Product: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.. 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)..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-22
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.