Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin… — Class III medical device recall Z-3196-2018
Terminated recall by Smiths Medical ASD Inc., reported 2018-09-26, distributed nationwide. The product was mislabeled with the incorrect label.
| Recall number | Z-3196-2018 |
|---|---|
| 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 | 2018-07-13 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2018-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 29,600 kits |
| Reason classes | labeling |
| Lot numbers | 3306404, 3314069, 3318698 |
| Model numbers | 4080P-2 |
Product
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Reason for recall
The product was mislabeled with the incorrect label.
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-3196-2018. 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.