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Open, Classified

MINISCAV (tm) Vacuum Pump

FDA Recall Z-2619-2023 · Posted 2023-09-20

Recalling FirmR A Medical Services
Recall StatusOpen, Classified
Product CodeBTA
Date Initiated2023-08-23
Product Quantity10 units

Reason for Recall

Inadequate documentation of acceptance activity

Firm Action

R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units.

Root Cause

Process control

Distribution Pattern

Distribution to Ohio

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160950MINISCAVSedation Systems, LLC · 2017-05-05

Official Source

View FDA Recall →

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

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