FDA Device recall Z-3196-2018
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on…
- FDA Device
- Class III
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class III recall of Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on… by Smiths Medical Asd, citing the product was mislabeled with the incorrect label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3196-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-13 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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
The product was mislabeled with the incorrect label.
Identifiers
| code_info | Lot numbers 3306404, 3314069, and 3318698. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3196-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.