Recall Z-0071-2019— Smiths Medical ASD Inc.
Class III · Terminated
Class III FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-07-06, terminated 2019-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.. Reason: "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-07-06
- Terminated
- 2019-04-30
- Firm location
- Minneapolis, MN, United States
Product description
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.