Z-1394-2017 Class II Terminated
FDA device recall Z-1394-2017 was initiated by Becton Dickinson & Co. on Aug 27, 2015 and is designated Class II. Reason for recall: BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would… The recall status is terminated (terminated Mar 6, 2017). Affected quantity: Qty Distributed to Field - 4,502.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 8, 2017
- Initiation Date
- Aug 27, 2015
- Termination Date
- Mar 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Qty Distributed to Field - 4,502
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1394-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026