Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK Recalled by American Contract Systems Inc. Due to Identified products were re-gassed (sterilized more than once)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Contract Systems Inc. directly.
Affected Products
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
Quantity: 32,433 total
Why Was This Recalled?
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Contract Systems Inc.
American Contract Systems Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report