Reported Mar 26, 2025 · Ongoing
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
- DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published CCDU12C00191072196323UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 CCDU12D00191072229472UDI-DI 00191072229472 Tray Lot 70-052444 CCDU12D-0100191072229472UDI-DI 00191072229472 Tray Lot 70-052967 - Amount recalled
- 1200 kits
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
- OH
Why it was recalled
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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