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 BFCT04X CATARACT PACK - 205986 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 BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
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