Luer tip caps recalled after trays failed routine biocompatibility testing
Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.
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: Scored 3 under the risk-of-harm criterion: a material failing biocompatibility testing on a fluid-path component is a hazard, and no injuries are reported.
Plain-English summary
BD Luer Tip Caps, catalog number 308341, are being recalled.
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
The recall covers 4,180,000 units carrying UDI-DI 50382903083416, from lots 5029670, 5034211 and 5041975. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
Biocompatibility testing checks that materials in contact with the patient or the fluid path do not cause an adverse biological response. The enforcement record reports no injuries. Facilities holding affected lots should quarantine them and follow BD's instructions.
The recalled product
- Product
- BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 4,180,000
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 (5)
- Catalog Number(s) or Model Number(s): 308341
- UDI-DI: 50382903083416
- Lot Numbers: 5029670
- 5034211
- 5041975
Distribution
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