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Z-0877-2017 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0877-2017 was initiated by Becton Dickinson & Co. on Feb 12, 2016 and is designated Class II. 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. The recall status is terminated (terminated Dec 27, 2016). Affected quantity: 16,682.396.

Recall Details

Product Type: Devices
Report Date: Dec 28, 2016
Initiation Date: Feb 12, 2016
Termination Date: Dec 27, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,682.396

Product Description

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.

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.

Distribution Pattern

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

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0877-2017
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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