[pending] Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE P
Pending LLM rewrite. Source: FDA_DEVICE Z-0185-2026.
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 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
- 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 (4)
- BFCT04X UDI-DI 191072225955 Lot 7992111 bag serial number N/A
- PERP25AQ UDI-DI 191072199720 lot 8078511 bag serial number 17507000
- RFEY50AC UDI-DI 191072202918 lot 8048811 bag serial number 17483686
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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