smiths medical portex First Breath Adult Nasal Cannula — Class III medical device recall Z-0071-2019
Terminated recall by Smiths Medical ASD Inc., reported 2018-10-10, distributed nationwide. "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was man
| Recall number | Z-0071-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-07-06 |
| Classified | 2018-10-04 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | PL, RU |
| Quantity | 12,000 devices |
| Reason classes | labeling |
| Lot numbers | 1703221A, 1705111A |
| Model numbers | 001283 |
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 for recall
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0071-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.