BD BBL CultureSwab EZ Collection and Transport System Swabs Breakage
BD BBL CultureSwab EZ Collection and Transport System (REF 220144) is being recalled because swabs may break during use. The recall affects units distributed nationwide in Maryland.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device with a structural/functional defect (swab breakage). The source text does not report any illnesses, injuries, or hospitalizations, making it a precautionary action; the hazard is potential product failure rather than direct patient harm.
Plain-English summary
The BD BBL CultureSwab EZ Collection and Transport System, REF 220144, is being recalled due to swabs that may be prone to breakage during product usage. The recalled product is an in vitro diagnostic device manufactured by Copan Italia.
The recall affects 81,600 units with Lot 2415377 (UDI: 38053326002145) that were distributed nationwide in the state of Maryland. Healthcare providers and laboratories using this product should not use the affected lot.
Users who have the recalled product should contact Copan Italia or their distributor for further guidance on product returns or replacement.
The recalled product
- Product
- BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
- Manufacturer
- Copan Italia
- Hazard
- Affected units
- 81,600
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: 2415377/UDI: 38053326002145
Distribution
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