FDA recall Z-2065-2020

Product

BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

Reason for recall

This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Distribution

Nationwide domestic distribution. Foreign distribution to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, New Zealand

Key facts

Status

Terminated

Initiation date

2020-04-16

Report date

2020-05-27

Termination date

2021-09-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2065-2020