Reported Sep 3, 2025 · Ongoing
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as
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
27 of 27 products
| Model / number | Product as published |
|---|---|
ANCV78BC | HEART PACK - 205947, MODEL/ |
ANVA82AB | VASCULAR PACK - 232024, MODEL/ |
BHOP48O | OFF PUMP CABG PACK - 170316, MODEL/ |
BHOP48P | OFF PUMP CABG PACK - 170316, MODEL/ |
BHPH18F | PEDIATRIC OPEN HEART PACK - 170212, MODEL/ |
BHPH18G | PEDIATRIC OPEN HEART PACK - 170212, MODEL/ |
HGCB98F | CABG ACCESSORY PACK, MODEL/ |
HGCV05K | CV SET UP PACK, MODEL/ |
HGOH99H | OPEN HEART PACK B - COMPONENTS, MODEL/ |
MHCV10AM | STRADLE TABLE PACK - 301659, MODEL/ |
MTVS73D | MINOR VASCULAR PACK, MODEL/ |
RCAV40C | AV GRAFT RCH 0246952, MODEL/ |
RCOH61G | OPEN HEART PART 1 RCH 0247159, MODEL/ |
TNCA08T | CARDIO 612968, MODEL/ |
TNCB10AM | CV B PACK, MODEL/ |
UDAV16AD | A-V FISTULA - 206042, MODEL/ |
UDCP24AF | CAROTID PACK - 206045, MODEL/ |
UDFP36AH | FEM POP PACK - 206052, MODEL/ |
UICD62AN | CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ |
UICS88S | SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ |
- Amount recalled
- 31506 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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