FDA Medical devices recall ·
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK… recall
- Recall number
- Z-0174-2026
- Date
- (initiated September 4, 2025)
- Company / brand
- American Contract Systems Inc
1601 Se Gateway Dr Ste 120, Grimes, IA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32,433 total
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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; UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283; UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number 17598793 * If Bag serial number is listed as "N/A", then whole lot is affected
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States: Iowa Illinois Minnesota South Dakota Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0174-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.