BD SafetyGlide Injection Needle Recall Due to Sterility Assurance Issues
Becton Dickinson is recalling 29,500 units of BD SafetyGlide Injection Needles because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level (SAL) standards.
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 where the failure to meet Sterility Assurance Level (SAL) standards poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Becton Dickinson & Company is recalling 29,500 units of BD SafetyGlide Injection Needles, Catalog #305917. The recall is due to the identification that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required for the device.
The affected product is intended for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, and injection into intravenous ports and tubings external to the patient. The device features a needlestick prevention mechanism that covers the needlepoint after use. The specific code information for the recalled units is 6022838 2021-01.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected needles and contact Becton Dickinson & Company for further instructions or replacement.
The recalled product
- Product
- BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The…
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 29,500
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)
- 6022838 2021-01
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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