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Terminated

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

FDA Recall Z-0318-2021 · Posted None

Recalling FirmOriGen Biomedical, Inc.
Recall StatusTerminated
Product CodeKFM
Date Initiated2019-06-24
Date Terminated2021-07-14
Product Quantity6 units

Reason for Recall

The firm has become aware that they have distributed product that was expired.

Firm Action

On 6/24/2019, a email was sent to the affected customer informing them that the product was expired and requesting that it be returned.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US: TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation · 2017-12-15

Official Source

View FDA Recall →

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

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