[pending] Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 20597
Pending LLM rewrite. Source: FDA_DEVICE Z-0174-2026.
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 BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO 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 (5)
- BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421
- CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370
- MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A
- PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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