The Recall Desk
HighFDA (Devices)·Z-0772-2014·Announced 2014-01-22

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.

What this means for you

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¿ injectio
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.