Low Volume Extension Set — Class II medical device recall Z-1730-2015
Terminated recall by Smiths Medical Asd Inc, reported 2015-06-17, distributed in KY, MN, NJ, UT, WI. Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where unde
| Recall number | Z-1730-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical Asd Inc, Dublin, OH, United States |
| Recall initiated | 2015-05-04 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-01-20 |
| Distributed | KY, MN, NJ, UT, WI |
| Quantity | 6,000 units |
| Lot numbers | 2761409 |
Product
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
Reason for recall
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
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-1730-2015. 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.