Smiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects
Smiths Medical is recalling 26,750 Acuvance 2 Safety Catheters because some devices have missing or incorrectly positioned side port valves.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional component (side port valve) in a medical device used for vascular access, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling 26,750 units of the Acuvance 2 Safety Catheter, product number 1720-AI. The recall involves three specific lots with codes 3120882, 3120883, and 3220733. These devices are peripheral intravenous catheters designed for single-use venipuncture to provide access to veins and arteries.
The recall was initiated because Smiths Medical became aware that the affected lots contain devices with missing or incorrectly positioned side port valves. The side port is equipped with a non-return silicone valve and a polypropylene snap cap, which are critical components for the catheter's function and safety.
The affected products were distributed in Italy, France, Switzerland, Germany, and Sweden. Healthcare providers and facilities that have received these specific lots should stop using the devices and contact Smiths Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 26,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 3120882
- 3120883
- 3220733
Distribution
Distribution scope not specified by the agency.
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