Portex Anaerobic Pulsator Arterial Blood Sampling Kit — Class III medical device recall Z-1028-2015
Terminated recall by Smiths Medical ASD, Inc., reported 2015-02-04, distributed in FL. The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marke
| Recall number | Z-1028-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2014-12-17 |
| Classified | 2015-01-28 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-06-25 |
| Distributed | FL |
| Quantity | 900 units |
| Reason classes | labeling |
| Lot numbers | 2782094 |
Product
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
Reason for recall
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
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-1028-2015. 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.