HIGH

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...

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.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter

Full Description

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. Reason: 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. Quantity: 32,433 total. Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421
CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370
IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124
MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A
PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184
+3 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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