Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reported: June 13, 2018 Initiated: April 2, 2018 #Z-2114-2018
Product Description
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reason for Recall
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 16 units
- Distribution
- Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Bivona¿ Tracheostomy Tube Tracheostomy Tubes. Recalled by Smiths Medical ASD Inc.. Units affected: 16 units.
Why was this product recalled? ▼
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2114-2018.
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