The Recall Desk
HighFDA (Devices)·Z-0877-2017·Announced 2016-12-28

BD SurePath Collection Vials Recalled Due to Cracked Caps

Becton Dickinson is recalling SurePath collection vials because cracked caps may allow preservative fluid to leak.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leaking fluid) where no specific injuries or illnesses are reported in the source text.

Plain-English summary

Becton Dickinson & Co. is recalling specific lots of BD SurePath Preservative Collection Vials. The affected products include catalog numbers 490505, 490527, 491095, 491096, and 491097. These vials are designed for use with the PrepStain System and contain an alcohol-based preservative fluid used for gynecologic specimens.

The recall was initiated because a portion of the collection vials associated with specific production lots may contain cracked caps. These cracks can lead to the leaking of the preservative fluid. The agency has classified this recall as Class II.

The affected products were distributed worldwide, including nationwide in the United States and to various international regions. The source text does not specify which consumers or healthcare facilities should take specific actions, such as returning the product or seeking medical attention, as the provided text is limited to the defect description.

The recalled product

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 trans
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Diagnostic Collection Vials
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Related recalls

Same manufacturer · Becton Dickinson & Co.

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