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U.S. Department of Health and Human Services

Class 2 Device Recall Accuvance Safety Catheter

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  Class 2 Device Recall Accuvance Safety Catheter see related information
Date Initiated by Firm November 21, 2016
Date Posted December 19, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-0789-2017
Recall Event ID 75742
510(K)Number K012128  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
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.
Code Information 3120882, 3120883, 3220733
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer 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.
FDA Determined
Cause 2		 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 Acuvance¿2 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 smithsmedicalrecall@stericycle.com.
Quantity in Commerce 26,750
Distribution Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ETHICON ENDO-SURGERY, INC.
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