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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Recall Number Z-1923-2013
Classification Class II
Code Info Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.
Product Distributed Qty 37,906,400 units
Reason For Recall BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

Event Detail

Event Id 65322
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 2013-05-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution