Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin… — Class II medical device recall Z-1716-2020
Terminated recall by Smiths Medical ASD, Inc., reported 2020-04-22, distributed in AL, AR, AZ, CA, CO, DE, FL, GA…. Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
| Recall number | Z-1716-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2020-01-07 |
| Classified | 2020-04-15 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2020-12-14 |
| Distributed | AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA |
| Quantity | 127,700 devices |
| Lot numbers | 3856947, 3859727, 3859751, 3859779, 3862142, 3862145, 3863522, 3863544, 3863545, 3869581, 4558PE, 4588P-2, 4599P-1, G1665, G1702, G1724 |
| Model numbers | 3856947, 3859727, 3859751, 3859779, 3862142, 3862145, 3863522, 3863544, 3863545, 3869581, 4558PE, 4588P-2, 4599P-1, G1665, G1702, G1724 |
Product
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Reason for recall
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
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-1716-2020. 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.