American Contract Systems Inc. recalls Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 191072235350
- Lot #
- 8531411 Bag
- Serial #
- 17705421; CMCP10X
- UDI
- 191072228215
- Lot #
- 8392411 Bag
- Serial #
- 17622370; IHCY10Y
- UDI
- 191072159922
- Lot #
- 8026111 Bag
- Serial #
- 17499185
- Lot #
- 8346211 Bag
- Serial #
- 17692649
- Lot #
- 8444211 Bag
- Serial #
- 17681124; MHCY35AE
- UDI
- 191072228864
- Lot #
- 7990511 Bag
- Serial #
- N/A; PLBY52E
- UDI
- 191072141415
- Lot #
- 8016811 Bag
- Serial #
- 17435184; UDCY31Z
- UDI
- 00191072213990
- Lot #
- 8043211 Bag
- Serial #
- 17483121 17483122 17483143 17483144 17485283; UICY28L
- UDI
- 191072205537
- Lot #
- 8217311 Bag
- Serial #
- 17598793 * If Bag
- Serial #
- is listed as "N/A", then whole
- Lot #
- is affected
Show 17 more code fieldsShow fewer
What the firm is doing
Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
DistributionShow detailsHide
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0174-2026
- FDA device classification · NWUOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find American Contract Systems Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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