Recalls / —
—#151123
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.
- FDA product code
- FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K012128
- Affected lot / code info
- 3120882, 3120883, 3220733
Why it was 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.
Root cause (FDA determination)
Process control
Action the firm took
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 smithsmedicalrecall@stericycle.com.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Timeline
- Recall initiated
- 2016-11-21
- Posted by FDA
- 2016-12-19
- Terminated
- 2017-08-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #151123. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.