BD Q-Syte Luer Access Split Septum Recalled for Leakage
Becton Dickinson is recalling BD Q-Syte Luer Access Split Septum units due to complaints of blood or medication leakage caused by silicone septum tearing.
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 defect (septum tearing) that causes leakage of blood or medication, representing a risk of harm where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Company is recalling 315,800 units of BD Q-Syte Luer Access Split Septum, Catalog REF #385100. The affected lots are #4128925 and #4128926. This product is an accessory to an intravascular administration set that permits injection, gravity flow, or withdrawal of fluids.
The recall was initiated because Becton Dickinson received an elevated number of complaints regarding blood or infusate/medication leakage. The source of the leakage is attributed to the tearing of the silicone septum.
The affected units were distributed to the states of California, Connecticut, Florida, Illinois, Massachusetts, North Dakota, New York, Ohio, and Pennsylvania. Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 315,800
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 (1)
- Lot #'s 4128925 and 4128926
Distribution
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