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Terminated

Prismaflex Control Unit

FDA Recall Z-2066-2020 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDI
Date Initiated2020-04-07
Date Terminated2021-11-09
Product Quantity5 devices US territories

Reason for Recall

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

Firm Action

Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to [email protected], and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local time, Monday through Friday.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution only to Puerto Rico and Guam

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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