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.
FDA Recall Z-0789-2017 · Posted 2016-12-19
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Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2016-11-21
Date Terminated2017-08-01
Product Quantity26,750
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.
Firm 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].
Root Cause
Process control
Distribution Pattern
Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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