American Contract Systems Inc.: Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
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- Company / brand
- American Contract Systems Inc.
- Product
- Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall initiated
- 2025-09-04
- Code info
- RCEN25B UDI-DI 191072225115 lot 8138311 bag serial number N/A; RCHN27D UDI-DI 191072235923 lot 8508211 bag serial number 47847459 * If bag serial number is listed as "n/a", then entire lot is affected
- Product quantity
- 32,433 total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Grimes
- State
- IA
- Country
- United States
- Event id
- 97659
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