Z-0072-2019 Class III Terminated
FDA device recall Z-0072-2019 was initiated by Smiths Medical ASD Inc. on Jul 6, 2018 and is designated Class III. Reason for recall: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured. The recall status is terminated (terminated Apr 30, 2019). Affected quantity: 2,550 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Jul 6, 2018
- Termination Date
- Apr 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,550 devices
Product Description
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Reason for Recall
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.
Code Information
Lot number 1705151A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0072-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026