RecallRadar

FDA Device recall Z-1830-2020

Prismaflex System, Prismaflex Control Unit

On 2020-05-06 the FDA classified a Class II recall of Prismaflex System, Prismaflex Control Unit by Baxter Healthcare, citing baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1830-2020
ClassificationClass II
Statusterminated
Initiated2020-02-06
Published2020-05-06
Last updated2026-09-13 11:55 UTC
CompanyBaxter Healthcare
DistributionPR

Product

Prismaflex System, Prismaflex Control Unit

Reason

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Identifiers

code_infoProduct Code: 114870; GTIN 07332414115395

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1830-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.