Agency classClass IIOur severity:High FDA (Devices)·Z-2065-2020·Announced 2020-05-27

BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a risk-of-harm product (compromised sterile field) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Becton Dickinson & Company is recalling 16,099,310 units of BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553, UDI 50382903065535). The recall covers specific lots including 8353952, 9011582, 9017875, 9024676, 9045702, 9060999, 9079716, 9127571, 9143529, 9156595, and 9163601.

The recall was initiated because the product has been confirmed to exhibit holes in the packaging. This defect impacts package integrity and potentially compromises a sterile field. The affected units were distributed domestically across the United States and internationally to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, and New Zealand.

Healthcare facilities and consumers should stop using the affected syringes and contact Becton Dickinson & Company for instructions on returning or disposing of the product.

The recalled product

Product: BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Syringes
Hazard: sterility-compromise
packaging-defect
Affected units: 16,099,310

Distribution

Distributed nationwide across the United States.

Same manufacturer · Becton Dickinson & Company

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