CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Acuvance¿2 Safety Catheter, Product No. 1720-AI recalled

Smiths Medical ASD is recalling Acuvance¿2 Safety Catheter, Product No. 1720-AI. The recall was initiated on 21 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes3120882, 3120883, 3220733

Quantity recalled26,750

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0789-2017
FDA event ID: 75742
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2016
FDA classified: 18 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Nov 2016	Recall initiated by company
18 Dec 2016	Classified by FDA	+27 days
28 Dec 2016	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

3120882, 3120883, 3220733

Where was it sold?

Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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