Centurion Recalls Convenience Kits Contaminated with Particulate Matter
Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.
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 involves a medical device with a risk of harm (particulate injection) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of convenience kits that contain SafetyGlide Needles (22GA 1-1/2in, Catalog n. 301701) manufactured by BD. The affected kits were distributed in the United States between May 2016 and June 2017.
The recall was initiated after Centurion received notice from BD regarding a recall of the needles. The issue involves particulate matter that could be expelled from the needle if it is used for injection. The recall includes various Centurion component codes such as CHT122O, CHT13OS, CHT154O, CVI3750, CV14265, CV14360, PT16O, and TC7910, with specific batch and expiration dates listed in the agency documentation.
Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory for the specific catalog numbers and batch codes identified in the recall notice. If the product has already been used, users should contact their healthcare provider for guidance.
The recalled product
- Product
- SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
- Manufacturer
- Centurion Medical Products Corporation
Distribution
Distribution scope not specified by the agency.
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