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CARDINAL HEALTH AT6688-2XLRecalls & reported problems

Cardinal Health 200, LLC · Isolation Gown; AAMI Level 3; Over-the-head; Elastic Wrist & Thumbhooks; Blue; 2X-Large · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 1, 2024Open, Classified

    Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

    Z-0675-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Other Gown, isolation, surgical devices

All Gown, isolation, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.