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)
FDA Recall Z-0175-2026 · Posted 2025-10-16
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Recalling FirmAmerican Contract Systems Inc.
Recall StatusOpen, Classified
Product CodeOES
Date Initiated2025-09-04
Product Quantity32,433 total
Reason for Recall
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.
Firm Action
Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.
Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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