FDAFDA · Food and drugs·Recall number Z-0877-2017
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.
Published December 28, 2016 · Recall initiated: February 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.