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Class 2 Device Recall BD SurePathTM Preservative Collection Vials |
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Date Initiated by Firm |
February 12, 2016 |
Create Date |
December 21, 2016 |
Recall Status1 |
Terminated 3 on December 27, 2016 |
Recall Number |
Z-0877-2017 |
Recall Event ID |
75886 |
PMA Number |
P970018 |
Product Classification |
Processor, cervical cytology slide, automated - Product Code MKQ
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Product |
BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097.
SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens. |
Code Information |
SurePath Collection Vial Replacement Cap, cat no. 490505 SurePath GYN Preservative Vial Kit, cat no. 490527 SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095 SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096 SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems Sparks MD 21152-9212
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For Additional Information Contact |
410-316-4000
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Manufacturer Reason for Recall |
BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
BD Life Sciences sent the initial recall notification on February 12, 2016. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS.
For further questions, please call (410) 316-4000. |
Quantity in Commerce |
16,682.396 |
Distribution |
Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan.
480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions.
15 US government sites received affected product |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = MKQ and Original Applicant = BD Diagnostic Systems
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