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Recall Observatory FDA recall evidence

Device product

DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

Z-1332-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
1200 kits
Official record key
device-enforcement:Z-1332-2025

Official wording

Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Code information: 1. Model No. CCDU12C UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 2. Model No. CCDU12D UDI-DI 00191072229472 Tray Lot 70-052444 3. Model No. CCDU12D-01 UDI-DI 00191072229472 Tray Lot 70-052967

Distribution pattern: US Nationwide distribution in the state of OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.