[pending] Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK
Pending LLM rewrite. Source: FDA_DEVICE Z-0181-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296
- HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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