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ACS MCBP83ERecalls & reported problems

American Contract Systems, Inc. · BIOPSY DRAPE PACK · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. May 6, 2024Open, Classified

    Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

    Z-2523-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS devices

All TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page