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Terminated

Sterile Custom Packs to be used in surgical procedures.

FDA Recall Z-2174-2020 · Posted None

Recalling FirmAmerican Contract Systems
Recall StatusTerminated
Product CodeOHM
Date Initiated2020-04-13
Date Terminated2020-11-25
Product Quantity2868 total kits

Reason for Recall

The surgical gowns were manufactured in a facility that is not registered by the FDA.

Firm Action

Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution including in the state of Pennsylvania.

Official Source

View FDA Recall →

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

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