Becton Dickinson Recalls BD Interlink Threaded Lock Cannula Due to Seal Defects
Becton Dickinson is recalling BD Interlink Threaded Lock Cannulas because some units may have open seals, compromising sterility.
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 compromised sterility poses a risk of harm (infection), 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 268,500 units of BD Interlink Threaded Lock Cannula, Reference # 303369, Lot # 3021392. The recall is due to the potential that a small percentage of the lot may exhibit open seals, which adversely impacts unit package integrity and product sterility.
The affected products were distributed nationwide in the United States and internationally to Canada and Japan. The device is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site.
Healthcare facilities and consumers should stop using the affected lot and contact Becton Dickinson for further instructions or replacement.
The recalled product
- Product
- BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿…
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — IV Cannula
- Affected units
- 268,500
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 (2)
- Marketing Status: Class II
- 510K # K011858 Device Listing Number: D043644 Lot number 3021392
Distribution
Distributed nationwide across the United States.
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