CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

BD Interlink threaded lock cannula This is a locking blunt recalled

Becton Dickinson & is recalling BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically, distributed nationwide in the US. The recall was initiated on 26 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMarketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392
Quantity recalled268,500 products

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0772-2014
FDA event ID
67098
Recalling firm
Becton Dickinson &, Franklin Lakes, NJ
Classification
Class II
Status
Terminated
Recall initiated
26 Nov 2013
FDA classified
15 Jan 2014
Reported
22 Jan 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

26 Nov 2013Recall initiated by company
15 Jan 2014Classified by FDA+50 days
22 Jan 2014Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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¿ injection site to provide a pathway for IV fluid administration.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.

Nationwide

Questions about this recall

Is BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically recalled?

Yes. Becton Dickinson & recalled BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically on 26 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0772-2014.

Why was it recalled?

BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.

Which lots are affected?

Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392

Where was it sold?

Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Becton Dickinson &

All 361

Other Heart & Vascular Devices recalls

All 6,199