Z-0789-2017 Class II Terminated
FDA device recall Z-0789-2017 was initiated by Smiths Medical ASD Inc. on Nov 21, 2016 and is designated Class II. 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. The recall status is terminated (terminated Aug 1, 2017). Affected quantity: 26,750.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Nov 21, 2016
- Termination Date
- Aug 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,750
Product Description
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.
Distribution Pattern
Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Code Information
3120882, 3120883, 3220733
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0789-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026