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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an InterlinkĀ® injection site. It is screwed down over the InterlinkĀ® injection site and a blunt plastic cannula inside the housing enters the InterlinkĀ® injection site to provide a pathway for IV fluid administration.
Recall Number Z-0772-2014
Classification Class II
Code Info Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644 Lot number 3021392
Product Distributed Qty 268,500 products
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.

Event Detail

Event Id 67098
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Company
City Franklin Lakes
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
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