Reported Sep 3, 2025 · Ongoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM…
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?
- AMERICAN CONTRACT SYSTEMS, Medical
- Procedure kits and trays labeled as
1) SFCH CRANI PACK (PS 132432)MODEL/ITEM NUMBER UICR10W2) SFCH SHUNT PACK (PS 139798)MODEL/ITEM NUMBER UISH55V
- Lot codes and dates
- 1)
- MODEL/ITEM NUMBER UICR10WUDI/DI 00191072207241
- Kit Lot Numbers
42-782871142-798071142-806321142-81240112)
- MODEL/ITEM NUMBER UISH55VUDI/DI 00191072235442
- Kit Lot Numbers
42-779911142-798521142-806511142-8140711
- Amount recalled
- 204 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
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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