American Contract Systems Inc: DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01

Hazard

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

Details from the source

Reason for recall: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. Distribution: US Nationwide distribution in the state of OH. Quantity: 1200 kits Lot/code info: 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

UPC codes

00191072196323, 00191072229472

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.