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NAMIC 60010508Recalls & reported problems

Medline Industries, Inc. · MTS RT HANDED/LFT HRT KIT-AUDUBON PG · Class 2

4 open recalls name 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
4

Summary

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

4 FDA recall records name this device's identifier, 4 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. Mar 24, 2026Open, Classified

    Medline has identified the presence of particulate within the fluid path of the Manifolds.

    Z-2147-2026 · Root cause: Under Investigation by firm · FDA record ↗

  2. Mar 24, 2026Open, Classified

    Medline has identified the presence of particulate within the fluid path of the Manifolds.

    Z-2145-2026 · Root cause: Under Investigation by firm · FDA record ↗

  3. Feb 27, 2026Open, Classified

    Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

    Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗

  4. Feb 27, 2026Open, Classified

    Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

    Z-1724-2026 · Root cause: Under Investigation by firm · FDA record ↗

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