FDA recall Z-0819-2022

Product

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U

Reason for recall

Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.

Distribution

US Distribution to states of: MA, VT

Key facts

Status

Terminated

Initiation date

2022-02-07

Report date

2022-03-30

Termination date

2023-12-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Breinigsville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2022