Z-0877-2017Class II

BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097...

Name: Z-0877-2017 BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097...
Creator: Becton Dickinson & Co.
Published: 2016-02-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-02-12 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with... on 2016-02-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0877-2017
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-12-21
Terminated: 2016-12-27
Recalling firm: Becton Dickinson & Co
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.
Product code: MKQ Processor, Cervical Cytology Slide, Automated
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0877-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

Product code MKQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)