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BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed...

FDA Recall #Z-0772-2014 — Class II — November 26, 2013

Recall #Z-0772-2014 Date: November 26, 2013 Classification: Class II Status: Terminated

Product Description

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.

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.

Recalling Firm

Becton Dickinson & Company — Franklin Lakes, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

268,500 products

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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