Acuvance¿2 Safety Catheter — Class II medical device recall Z-0789-2017
Terminated recall by Smiths Medical ASD Inc., reported 2016-12-28. Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain
| Recall number | Z-0789-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2016-12-18 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-08-01 |
| Countries outside the US | CH, DE, FR, IT, SE |
| Quantity | 26,750 |
Product
Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.
Reason for recall
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
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-0789-2017. 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.