Z-0789-2017Class II

Acuvance2 Safety Catheter, Product No. 1720-AI

Name: Z-0789-2017 Acuvance2 Safety Catheter, Product No. 1720-AI
Creator: Smiths Medical ASD Inc.
Published: 2016-11-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-11-21 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed... on 2016-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0789-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-19
Terminated: 2017-08-01
Recalling firm: Abbott Medical
Product: Acuvance2 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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 11/21/2016 a Smiths Medical "Urgent Medical Device Field Safety Notice: dated November 18, 2016. The letter was addressed to "Clinician who uses the Acuvance2 Safety Catheter". The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to complete and return the "Urgent Medical Device Field Safety Notice Response Form" within 10 days of receipt. For questions contact Stericycle via email at the [email protected].
Quantity in commerce: 26,750
Distribution: Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Product codes and lots: 3120882, 3120883, 3220733

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0789-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-18

Product code FOZ

K012128Class IIProtectiv Acuvance IV Catheter SystemEthicon Endo-Surgery, Inc. / cleared 2001-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)