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Terminated

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

FDA Recall Z-0851-2019 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2018-12-21
Date Terminated2020-04-30
Product Quantity24

Reason for Recall

The products were manufactured with longer than specified sheaths.

Firm Action

Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.

Official Source

View FDA Recall →

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

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